AzTrials
AzTrials

Ovarian CancerPhase 3NCT00849667

Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

A Phase 3 study testing Farletuzumab, Carboplatin and Taxane in people with Ovarian Cancer, run by Morphotek at 375 sites in 30 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Farletuzumab, Carboplatin and Taxane
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,100 participants
Where
375 sitesin 30 countries
Study dates
16 Apr 2009to 12 Apr 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
  • Must have measurable disease by CT or MRI scan
  • Must have relapsed radiologically with a randomization date within ≥6 and < 24 months of completion of first-line platinum chemotherapy
  • Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
  • Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
  • Must be a candidate for carboplatin and taxane therapy
  • Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

Who cannot join

  • Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy
  • Subjects who have received other therapy to treat their ovarian cancer since relapse
  • Known central nervous system (CNS) tumor involvement
  • Evidence of other active invasive malignancy requiring treatment in the past 5 years
  • Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
  • Previous treatment with MORAb-003 (farletuzumab)
  • Clinical contraindications to use of a taxane

Trial locations and contacts

375 sites in 30 countries.

375 sites in 30 countries

United States110 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Northern Virginia Pelvic Surgery Associates

    Annandale, Virginia, 22003

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • University of Colorado

    Aurora, Colorado, 80045

  • Texas Oncology, PA

    Austin, Texas, 78705

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • John Hopkins University

    Baltimore, Maryland, 21231

  • Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland, 21237-3998

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • University Of Alabama At Birmingham

    Birmingham, Alabama, 35233

  • Palm Beach Institute of Hematology and Oncology

    Boynton Beach, Florida, 33435

  • University Cancer Institute

    Boynton Beach, Florida, 33435

  • Harrison Bremerton Hematology and Oncology

    Bremerton, Washington, 98310

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence St. Joseph Medical Center

    Burbank, California, 91505

  • The Center for Cancer and Hematologic Disease

    Camden, New Jersey, 08003

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

  • Catholic Health Initiatives

    Cincinnati, Ohio, 45220

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44195

  • Catholic Health Initiatives

    Colorado Springs, Colorado, 80907

  • Texas Oncology, PA

    Dallas, Texas, 75231

  • Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204

  • Hematology-Oncolgy Associates of NNJ-PA

    Denville, New Jersey, 07834

  • Barbara Ann Kamanos Cancer Center

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Oncology Hematology Associates

    DuBois, Pennsylvania, 15801

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Providence Everett Medical Center

    Everett, Washington, 98201

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Gainsville Hematology Oncology Associates

    Gainesville, Florida, 32605

  • Medical & Surgical Specialists, LLC

    Galesburg, Illinois, 61401

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Saint Francis Memorial Health Center

    Grand Island, Nebraska, 68803

  • Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • California Cancer Care, Inc.

    Greenbrae, California, 94904

  • John Theurer Cancer Center at Hackensack University MC

    Hackensack, New Jersey, 07601

  • International Beneficence Clinical Research, L.L.C.

    Harlingen, Texas, 78550

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60425

  • Kaiser Permanente - Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Kapi'olani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • University of Texas Health Science Center at Houston Medical School

    Houston, Texas, 77030

  • Oncology Specialties, PC

    Huntsville, Alabama, 35801

  • St. Francis Hospital & Health Centers

    Indianapolis, Indiana, 46237

  • St. Vincent Gynecologic Oncology

    Indianapolis, Indiana, 46260

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Jupiter Medical center Physician's Group

    Jupiter, Florida, 33458

  • Good Samaritan Hospital Cancer Center

    Kearney, Nebraska, 68847

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • University of California San Diego

    La Jolla, California, 92093-0698

  • Arena Oncology Associates

    Lake Success, New York, 11042

  • Hematology/Oncology Associates

    Lake Worth, Florida, 33461

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • University of California Los Angeles Medical Center

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • Norton Healthcare

    Louisville, Kentucky, 40207

  • Loyola University Chicago

    Maywood, Illinois, 60153

  • Hematology & Oncology Specialists

    Metairie, Louisiana, 70006

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Columbia University Medical Center

    New York, New York, 10032

  • Gynecologic Oncology Associates

    Newport Beach, California, 92663

  • Peninsula Cancer Institute - Riverside Gynecology Oncology

    Newport News, Virginia, 23601

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Florida Hospital

    Orlando, Florida, 32804

  • Arizona Hematology & Oncology Associates

    Phoenix, Arizona, 85012

  • St. Joseph's Hospital, Barrow Neurology Clinics

    Phoenix, Arizona, 85013

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Providence Oncology & Hematology Care

    Portland, Oregon, 95213

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Park Nicollet Institute

    Saint Louis Park, Minnesota, 55426

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • South Texas Oncology and Hematology, PA

    San Antonio, Texas, 78229

  • Sarasota Memorial Healthcare System

    Sarasota, Florida, 34239

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Midwest Cancer Research Group

    Skokie, Illinois, 60625

  • Cancer Care Northwest-South

    Spokane, Washington, 99202

  • Willamette Valley Cancer Center

    Springfield, Oregon, 97477

  • Gulfcoast Oncology

    St. Petersburg, Florida, 33705

  • Hematology Oncology P.C.

    Stamford, Connecticut, 06902

  • Stanford University

    Stanford, California, 94305

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Oncology-Hematology Associates of W. Broward P.A.

    Tamarac, Florida, 33321

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Arizona Oncology Associates

    Tucson, Arizona, 85712

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684

  • Cooper Cancer Institute

    Voorhees Township, New Jersey, 08043

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Aurora Health Care

    West Allis, Wisconsin, 53227

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • US Oncology Research

    Wichita Falls, Texas, 76310

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Piedmont Hematology & Oncology

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan30 sites

  • Study site

    Akashi

  • Study site

    Amagasaki

  • Study site

    Chiba

  • Study site

    Fukuoka

  • Study site

    Hidaka

  • Study site

    Hiroshima

  • Study site

    Kagoshima

  • Study site

    Kashiwa

  • Study site

    Kawasaki

  • Study site

    Kōtoku

  • Study site

    Kumamoto

  • Study site

    Kure

  • Study site

    Kurume

  • Study site

    Matsuyama

  • Study site

    Minatoku

  • Study site

    Morioka

  • Study site

    Nagoya

  • Study site

    Nakano

  • Study site

    Niigata

  • Study site

    Okayama

  • Study site

    Osaka

  • Study site

    Sapporo

  • Study site

    Sayama

  • Study site

    Sendai

  • Study site

    Shinjuku-Ku

  • Study site

    Sunto-Gun

  • Study site

    Tsu

  • Study site

    Tsukuba

  • Study site

    Yamagata

  • Study site

    Yonago

Other trials in Japan

Italy26 sites

  • Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo

    Alessandria, 15100

  • Centro di Riferimento Oncologico

    Aviano, Pordenone, 33081

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

    Bologna, 40138

  • Istituto Ospedaliero Fondazione Poliambulanza

    Brescia, 25124

  • Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche

    Campobasso, 86100

  • Azienda Ospedaliera Cannizzaro

    Catania, 95126

  • Humanitas Centro Catanese di Oncologia

    Catania, 95126

  • Azienda Ospedaliera Sant'Anna

    Como, 22100

  • Ospedale di Faenza

    Faenza, 48018

  • Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Presidio Ospedaliero Vito Fazzi

    Lecce, 73044

  • Ospedale Mater Salutis ULSS 21 della regione Veneto

    Legnago, 37045

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST

    Meldola, 47014

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20132

  • Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Ospedaliera Niguarda Cà Granda

    Milan, 20162

  • Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Giovanni Pascale"

    Naples, 80131

  • Ospedale Sacro Cuore Don Calabria

    Negrar, 37024

  • Istituto Oncologico Veneto

    Padova, 35128

  • Ospedale Santa Maria della Misericordia di Perugia

    Perugia, 06132

  • Ospedale Santa Maria delle Croci

    Ravenna, 48100

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Azienda Policlinico Umberto I

    Roma, 00161

  • Policlinico Universitario "A. Gemelli"

    Roma, 00168

  • Azienda Ospedaliero-Universitaria di Udine

    Udine, 33100

Other trials in Italy

Brazil21 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, 14784-400

  • Instituto de Pesquisas Clínicas para Estudos Multicêntricos

    Caxias do Sul, 95070-560

  • Santa Casa da Misericórdia de Curitiba

    Curitiba, 80010-030

  • Instituto do Câncer do Ceará - ICC

    Fortaleza, 60430-230

  • Hosp. Araujo Jorge

    Goiânia, 74605-160

  • Associação Hospital de Caridade Ijuí

    Ijuí, 98700-000

  • Clinica de Neoplasias Litoral

    Itajaí, 88301-220

  • Hospital Amaral Carvalho

    Jaú, 17210-120

  • Liga Norte-Riograndense Contra o Câncer

    Natal, 59062-000

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90050-170

  • Clínica de Oncologia de Porto Alegre S/S Ltda

    Porto Alegre, 90430-090

  • Instituto Ribeirãopretano de Combate ao Câncer

    Ribeirão Preto, 14015-130

  • Clínica Oncologistas Associados

    Rio de Janeiro, 22260-020

  • INCA - Instituto Nacional do Câncer

    Rio de Janeiro - RJ, 20220-410

  • Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

    Salvador, 40050-410

  • Clínica AMO - Assistência Multidiciplinar em Oncologia

    Salvador, 41825-010

  • Centro de Estudos de Oncologia da FMABC

    Santo André, 09060-650

  • Saúde ABC Serviços Médicos Hospitalares Ltda

    Santo André, 09090-780

  • Instituto do Câncer Arnaldo Vieira de Carvalho

    São Paulo, 01209-000

  • Certo Oncologia

    São Paulo, 04551-010

  • Hospital Premier

    São Paulo, 04583-100

Other trials in Brazil

India18 sites

  • Kidwai Memorial Institute of Oncology

    Bangalore, Karnataka, 560032

  • M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board

    Bangalore, 560054

  • Jawaharlal Nehru Cancer Hospital & Research Centre

    Bhopal, Madhya Pradesh, 462001

  • Dr. Kamakshi Memorial Hospital

    Chennai, Tamil Nadu, 600100

  • Apollo Hospitals International Limited

    Gandhinagar, Gujarat, 382428

  • MNJ Institute of Oncology and Regional Cancer Centre

    Hyderabaad, 500004

  • SK Soni Hospital

    Jaipur, 302013

  • Bhagwan Mahaveer Cancer Hospital and Research Centre

    Jaipur, 302017

  • Amrita Institute of Medical Sciences and Research Centre

    Kochi, 682026

  • Lakeshore Hospital

    Kochi, 682304

  • Chittaranjan National Cancer Institute

    Kolkata, West Bengal, 700026

  • Tata Memorial Hospital

    Mumbai, 400012

  • Curie Manavata Cancer Centre

    Nashik, 422004

  • Shatabdi Superspeciality Hospital

    Nashik, 422005

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Jehangir, Clinical Development Centre

    Pune, Maharashtra, 411001

  • Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Regional Cancer Centre

    Trivandrum, 695011

Other trials in India

Germany17 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Helios Klinikum Berlin-Buch

    Buch, 13125

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Marien-Hospital Akademisches Lehrkrankenhaus

    Düsseldorf, 40479

  • Frauenarztpraxis Dr. med. Gröll de Rivera

    Ebersberg, 85560

  • Universitätsklinikum Essen

    Essen, 45122

  • Krankenhaus Nordwest

    Frankfurt, 60488

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Kath. Marienkrankenhaus gGmbH

    Hamburg, 22087

  • Universität Heidelberg

    Heidelberg, 69120

  • St. Vincentius Kliniken Karlsruhe

    Karlsruhe, 76135

  • Universitätsklinik Magdeburg

    Magdeburg, 39108

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Klinikum der Universität München - Innenstadt

    München, 80337

  • Rotkreuzklinikum München

    München, 80637

  • Klinikum Südstadt Rostock

    Rostock, 18059

  • Klinikum Traunstein

    Traunstein, 83278

Other trials in Germany

Spain15 sites

  • Fundacion Hospital Alcorcon

    Alcorcón, Madrid, Communidad de, 28922

  • Hospital Universitario Vall D'Hebron

    Barcelona, Catalonia, 08035

  • Hospital Clinic i Provincial

    Barcelona, Catalonia, 08036

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • Hospital General Universitario de Elche

    Elche, Valencia, 03203

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Communidad de, 28007

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Communidad de, 28034

  • Hospital 12 de Octubre

    Madrid, Madrid, Communidad de, 28041

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital de Mataró

    Mataró, Catalonia, 08034

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198

  • Corporació Sanitaria Parc Taulí

    Sabadell, Catalonia, 08208

  • Hospital Virgen del Rocio

    Seville, Andalusia, 41013

  • Hospital Mutua de Terrassa

    Terrassa, Catalonia, 08221

  • Fundación Instituto Valenciano de Oncología

    Valencia, Valencia, 46009

Other trials in Spain

United Kingdom13 sites

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Velindre Hospital

    Cardiff, CF14 2TL

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Beatson Oncology Centre

    Glasgow, G12 0YN

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Hammersmith Hospital

    London, W12 0HS

  • Clatterbridge Centre For Oncology

    Metropolitan Borough of Wirral, CH63 4JY

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Poole Hospital NHS Trust

    Poole, BH15 2JB

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Argentina12 sites

  • Hospital Zonal Especializado en Oncología de Lanús

    Buenos Aires, 1824

  • Consultorios Medicos Privados SA

    Buenos Aries, 1704

  • Fundación Sanatorio Güemes

    CABA, 1180

  • Clinica Universitaria Reina Fabiola

    Códoba, 5004

  • Instituto Medico Platense

    La Plata, 1900

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Hospital Bocalandro

    Loma Hermosa, 1657

  • Centro Oncologico Integral

    Mar del Plata, B7600LTO

  • CER Instituto Medico

    Quilmes, B1878DVB

  • Centro Médico San Roque

    San Miguel de Tucumán, 4000

  • Centro Medico de Alta Complejidad Cemac

    San Salvador de Jujuy, 4600

  • ISIS Centro Especializado de LUCE SA

    Santa Fe, S3000FFU

Other trials in Argentina

Poland12 sites

  • Bialostockie Centrum Onkologii

    Bialystok, 15-027

  • Wojewodzkie Centrum Onkologii

    Gdansk, 80-219

  • Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach

    Gliwice, 44-100

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

    Lodz, 93-509

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090

  • Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii

    Olsztyn, 10-228

  • Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o.

    Olsztyn, 10-513

  • Wielkopolskie Centrum Onkologii

    Poznan, 61-866

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna

    Poznan, 61-878

  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

    Rybnik, 44-200

  • Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie

    Szczecin, 70-111

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

Other trials in Poland

Israel10 sites

  • Rambam Medical Center

    Haifa, 31096

  • Linn Medical Center, Clalit Health Services

    Haifa, 35152

  • Wolfson Centre

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

  • Assaf Harofe Medical Center

    Tsrifin, 70300

Other trials in Israel

Russia8 sites

  • Kursk Regional Oncology Centre

    Kursk, 305035

  • Russian Oncology Research Center named after N.N. Blokhin

    Moscow, 115478

  • Russian Oncology Research Center

    Moscow, 115478

  • Moscow Research Oncology Institute n.a. P.A.Gertsen

    Moscow, 125284

  • Medical Radiology Research Center of RAMS

    Obninsk, 249036

  • Ryazan Regional Clinical Oncology Dispensary

    Ryazan, 390011

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare

    Ufa, 450054

Other trials in Russia

Belgium7 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

  • AZ Groeninge - Campus Maria's Voorzienigheid

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • CHU de Liège

    Liège, 4000

  • Sint-Augustinuskliniek

    Wilrijk, 2610

Other trials in Belgium

Hungary7 sites

  • Semmelweis Egyetem

    Budapest, 1082

  • Semmelweis Egyetem

    Budapest, 1088

  • Petz Aladár Megyei Oktató Kórház

    Győr, 9024

  • Bács-Kiskun Megyei Önkormányzat Kórháza

    Kecskemét, 6000

  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

    Miskolc, 3526

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet

    Szolnok, 5004

  • Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet

    Veszprém, 8200

Other trials in Hungary

South Korea7 sites

  • National Cancer Center

    Gyeonggi-do, 410-769

  • Gachon University Gil Medical Center

    Incheon, 405760

  • Cheil General Hospital & Women's Healthcare Center

    Seoul, 100380

  • Seoul national univercity hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University College of Medicine

    Seoul, 120752

  • Samsung Medical Center

    Seoul, 135710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Australia6 sites

  • The Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • North Adelaide Oncology Clinical Trials

    North Adelaide, South Australia, 5006

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Tweed Hospital

    Tweed Heads, New South Wales, 2485

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N-4N2

  • Cancer Center For The Southern Interior

    Kelowna, British Columbia, V1Y5L3

  • The Moncton Hospital

    Moncton, New Brunswick, E1C6Z8

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • British Columbia Cancer Agency

    Surrey, British Columbia, V3V 1Z2

  • BCCA

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Philippines6 sites

  • Cebu Gynecologic Cancer Care Clinic

    Cebu, 6000

  • Perpetual Succour Hospital

    Cebu City, Cebu, 6000

  • Manila Doctors Hospital

    Manila, 1000

  • San Juan de Dios Hospital

    Pasay, 1300

  • St. Luke's Medical Center

    Quezon City, 1102

  • National Kidney and Transplant Institute

    Quezon City, 1112

Other trials in Philippines

Taiwan6 sites

  • National Cheng Kung University Hosptial

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 104

  • Taipei Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 114

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

France5 sites

  • Centre Régional de lutte contre le cancer Paul Papin

    Angers, 49933

  • Centre Hospitalier Louis Pasteur

    Le Coudray, 28630

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hôpital Saint Louis

    Paris, 75475

  • Institut Jean Godinot - Centre de lutte contre le cancer

    Reims, 51056

Other trials in France

Greece5 sites

  • Alexandra Hospital

    Athens, 115 28

  • General Oncology Hospital Kifissias "Oi Agioi Anargyroi"

    Athens, 145 64

  • University General Hospital of Heraklion

    Heraklion, Crete, 71110

  • University General Hospital of Patras

    Pátrai, 26500

  • Papageorgiou General Hospital

    Thessaloniki, 564 29

Other trials in Greece

Portugal5 sites

  • Hospitais da Universidade de Coimbra

    Coimbra, 3000-075

  • Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE

    Coimbra, 3000-075

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE)

    Lisbon, 1099-023

  • Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)

    Porto, 4200-072

  • Hospital de São João

    Porto, 4200-319

Other trials in Portugal

Netherlands4 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 HX

  • Orbis Medisch Centrum

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Ukraine4 sites

  • Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary"

    Cherkasy, 18009

  • Chernivtsi Regional Clinical Oncology Dispansery

    Chernivtsi, 58013

  • Kiev City Oncology Hospital

    Kyiv, 03115

  • Volyn Regional Oncology Dispensary

    Lutsk, 43018

Other trials in Ukraine

Austria3 sites

  • Kaiser-Franz-Josef Spital

    Vienna, 1100

  • Krankenhaus Wien-Hietzing

    Vienna, 1130

  • Landeskrankenhaus Villach

    Villach, 9500

Other trials in Austria

Chile3 sites

  • Instituto de Terapias Oncologicas

    Santiago, 7501088

  • Instituto Clínico Oncológico del Sur

    Temuco, 4810469

  • Instituto Oncologico Ltda.

    Viña del Mar

Other trials in Chile

Mexico3 sites

  • Union Medica Quirurgica de Colima

    Colima, 3402

  • Triva Investigaciones Medicas Sociedad Anónima de Capital Variable

    Morelia, 58000

  • Hospital Regional de Veracruz

    Veracruz, 91700

Other trials in Mexico

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • National Cancer Centre

    Singapore, 169610

  • KK Women's and Children's Hospital

    Singapore, 229899

Other trials in Singapore

Hong Kong2 sites

  • Queen Mary Hospital

    Pokfulam, Islands

  • Tuen Mun Hospital

    Tuenmen

Other trials in Hong Kong

Switzerland1 site

  • Universität Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Conditions
Ovarian Cancer
Being tested
Farletuzumab, Carboplatin, Taxane, Farletuzumab-matched placebo
Keywords
ovarian cancer, relapsed ovarian cancer, Platinum-sensitive Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FarletuzumabDrug

    Also called MORAb-003

    Farletuzumab IV infusion.

  • CarboplatinDrug

    Carboplatin IV infusion.

  • TaxaneDrug

    Taxane (Paclitaxel or Docetaxel) IV infusion.

  • Farletuzumab-matched placeboDrug

    Farletuzumab-matched placebo IV infusion.

Study groups in NCT00849667
Study groupRoleWhat they receive
Farletuzumab (1.25 mg/kg)Active comparatorParticipants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel [175 milligram per meter square {mg/m^2}] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain area under curve [AUC] 5-6 milligram per milliliter per minute [mg/mL/minute]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.
Receives: Drug: Farletuzumab; Drug: Carboplatin; Drug: Taxane
Farletuzumab (2.5 mg/kg)Active comparatorParticipants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.
Receives: Drug: Farletuzumab; Drug: Carboplatin; Drug: Taxane
PlaceboPlacebo comparatorParticipants will receive farletuzumab-matched placebo (0.9 percent [%] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.
Receives: Drug: Carboplatin; Drug: Taxane; Drug: Farletuzumab-matched placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors [RECIST]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).

    Measured: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

Secondary outcomes (18)

  1. Overall Survival (OS)

    OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.

    Measured: From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)

  2. Cancer Antigen-125 (CA-125) Progression-Free Survival

    CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (>=) 2 multiple (*) ULN with either event documented on two occasions or CA-125 >=2*nadir value with either event documented on two occasions.

    Measured: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

  3. Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria

    PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 >=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 >=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 >=two times ULN on two occasions at least one week apart.

    Measured: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

  4. Percentage of Participants With Length of Second Remission Greater Than First Remission

    Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.

    Measured: From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)

  5. Percentage of Participants With Objective Response

    Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

    Measured: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)

  6. Duration of Tumor Response

    Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.

    Measured: From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)

  7. Time to Tumor Response (TTR)

    Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.

    Measured: From the date of randomization to first documentation of objective response (up to 48 months)

  8. Percentage of Participants With Serologic Response (SR)

    SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample.

    Measured: Up to 48 months

  9. Duration of 50% Serologic Response

    Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

    Measured: From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)

  10. Time to 50% Serologic Response (TSR)

    TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

    Measured: From the date of randomization to first documentation of 50% SR (up to 48 months)

  11. Percentage of Participants With Clinical Benefit

    Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.

    Measured: Up to 48 months

  12. Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel

    Measured: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

  13. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel

    Measured: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

  14. AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel

    Measured: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

  15. T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel

    Measured: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

  16. CL: Clearance of Total Carboplatin and Total Paclitaxel

    Measured: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

  17. Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel

    Measured: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

  18. Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores

    Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment.

    Measured: Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2009 (estimated)
  2. Study start16 Apr 2009
  3. Primary completion31 Dec 2012
  4. Study completion12 Apr 2013

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00849667
Sponsor's protocol ID
MORAb003-004
Other IDs
2008-005872-29, 2008
Status last verified
Nov 2022
First submitted
13 Feb 2009
Last updated
30 Dec 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Farletuzumab, Carboplatin and Taxane in people with Ovarian Cancer, run by Morphotek at 375 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 375 sites in United States, Japan, Italy, Brazil, India and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00849667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.

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