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Carcinoma, Squamous Cell of Head and NeckPhase 2/3NCT00412776

Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

A Phase 2/3 study testing Proxinium in people with Carcinoma, Squamous Cell of Head and Neck and Carcinoma, Squamous Cell, run by Sesen Bio, Inc. at 122 sites in 18 countries.

Terminated

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

Official record
Search all trials

Trial summary

The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Proxinium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
122 sitesin 18 countries
Study dates
Dec 2005to Apr 2008
Phase
Phase 2/3
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease Characteristics
  • The patient must be 18 years of age or older.
  • The patient must have squamous cell carcinoma of the head and neck.
  • The squamous cell carcinoma must be Ep-CAM positive.
  • ECOG performance status of 0, 1, 2 or 3.
  • 12 week life expectancy
Show all 18Show fewer
  • Prior/Concurrent Therapy
  • The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).
  • The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour.
  • The patient's disease must be refractory.
  • There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug.
  • Patient Characteristics
  • The patient must have adequate hepatic function [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN].
  • The patient must have adequate renal function (serum creatinine < 1.5 × ULN).
  • The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin >8 g/dL.
  • The patient must have prothrombin time and partial thromboplastin time within normal limits.
  • Other
  • Women of childbearing potential and male patients must agree to use a highly effective contraceptive method.

Who cannot join

  • The patient has clinically significant distant metastases.
  • The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy.
  • The patient has a nasopharyngeal tumour.
  • The patient has AIDS, hepatitis C or hepatitis B.
  • The patient has clinically significant renal or hepatic disease.
  • Tumors are prone to bleeding.
Show all 9Show fewer
  • The patient is pregnant or lactating.
  • The patient requires 'blood thinning' medications and can not safely discontinue the medication.
  • The patient is currently enrolled in another clinical trial.

Trial locations and contacts

122 sites in 18 countries.

122 sites in 18 countries

Brazil17 sites

  • Hospital de Câncer de Barretos - Fundação Pio XII

    Barretos

  • Cettro - Centro de Tratamento Oncológico Ltda.

    Brasília

  • Centro Regional Integrado de Oncologia - CRIO

    Fortaleza

  • Hospital Araújo Jorge

    Goiania - GO

  • Hospital Amaral Carvalho

    Jaú

  • Pro-Onco Centro De Tratamento Oncológico S/C Ltda

    Londrina

  • Biocor - Hospital de Doenças Cardiovasculares Ltda

    Nova Lima

  • CECAN - Centro do Câncer Francisco Cunha Filho

    Piracicaba

  • Hospital São Lucas da PUCRS

    Porto Alegre - RS

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre - RS

  • Instituto Ribeirãopretano de Combate ao Câncer

    Riberao Preto-SP

  • INCA - Instituto Nacional do Câncer

    Rio de Janeiro

  • SOS Vida - Soluções em Saúde

    Salvador - BA

  • Santo André Diagnósticos e Tratamentos Ltda

    Santo Andre-SP

  • Hospital Do Câncer A. C. Camargo

    São Paulo

  • Grupo de Pesquisas Médicas

    São Paulo - SP

  • Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo

    São Paulo - SP

Other trials in Brazil

India17 sites

  • Department of Medical Oncology, Bangalore Institute of Oncology

    Bangalore

  • Kidwai Memorial Institute of Oncology

    Bangalore

  • Global Hospitals

    Hyderabaad

  • MNJ Institute of Oncology

    Hyderabaad

  • Nizam's Institute of Medical Sciences

    Hyderabaad

  • Birla Cancer Institute SMS Medical College Hospital

    Jaipur

  • SK Soni Hospital

    Jaipur

  • Soumya Hospita

    Karkhāna

  • Amrita Institute of Medical Sciences and Research Centre

    Kochi

  • Netaji Subash Chandra Bose Cancer Research Institute

    Kolkata

  • Orchid Nursing Home

    Kolkata

  • Department of Medical Oncology Dayanand Medical College & Hospital

    Ludhiana

  • Asian Institute of Oncology, S L Raheja Hospital

    Mumbai

  • Tata Memorial Hospital

    Mumbai

  • Department of Medical Oncology AIIMS, Institute Rotary Cancer Hospital

    New Delhi

  • Department of Medical Oncology Rajiv Gandhi Cancer Institute and Research Centre

    New Delhi

  • Regional Cancer Centre

    Trivandrum

Other trials in India

Russia14 sites

  • Regional Oncology Dispensary

    Astrakhan

  • State Medical Institution Kursk Regional Oncology Dispensary Out-patient department

    Kursk

  • Central Clinical Hospital #2 after MA Semashko OAO "RRW"

    Moscow

  • Moscow Scientific-Research Oncology Institute after P.A. Gertsen

    Moscow

  • SI Russian Oncology Scientific Center after NN Blokhin RAMS

    Moscow

  • PHI OAO RRW Railway Clinical Hospital at station Gorkiy

    Nizhny Novgorod

  • Stavropol Regional Oncology Center, Pyatigorsk branch Out-patient department

    Pyatigorsk

  • SIH Leningrad Regional Oncology Dispansery

    Saint Petersburg

  • SPBSIH City Clinical Oncology Dispensary

    Saint Petersburg

  • PHI Dorozhnaya Clinical Hospital at Saratov II Station of Pryvolzhskaya railway OAO Russian Railways

    Saratov

  • Tambov Regional Oncological Dispensary Surgery Department

    Tambov

  • Republican Clinical Oncological Dispenser Radiological Therapy

    Ufa

  • State Medical Institution Regional Clinical Oncology Dispensary

    Ulyanovsk

  • Sverdlovsk Regional Oncology Dispensary

    Yekaterinburg

Other trials in Russia

Germany9 sites

  • Charité -Universitätsmedizin Berlin

    Berlin

  • Universitätsklinikum Köln

    Cologne

  • Medizinische Hochschule Hannover

    Hanover

  • Universität Heidelberg

    Heidelberg

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsklinikum Schleswig Holstein

    Lübeck

  • Johannes Gutenberg-Universität

    Mainz

  • Klinikum der Philipps-Universität Marburg

    Marburg

  • Universitätsklinikum Tübingen

    Tübingen

Other trials in Germany

Argentina8 sites

  • Hospital Italiano Regional del Sur

    Bahía Blanca

  • Hospital Municipal de Agudos Leonidas Lucero

    Bahía Blanca

  • Centro de Estudio y Tratamiento de las Enfermedades Neoplasicas (CETEN)

    Buenos Aires

  • Hospital de Clinicas "Jose de San Martin"

    Buenos Aires

  • Hospital Nacional Alejandro Posadas

    Buenos Aires

  • Hospital Universitario Austral

    Buenos Aires

  • Instituto Medico Platense

    La Plata

  • Hospital Italiano Garibaldi

    Rosario

Other trials in Argentina

Israel7 sites

  • Soroka University Medical Center

    Beersheba

  • The Lady Davis Carmel Medical Center

    Haifa

  • Haddasa Ein Carem Hospital

    Jerusalem

  • Rabin Medical Center

    Petah Tikva

  • Kaplan Medical Center

    Rehovot

  • Tel Aviv University Medical School

    Tel Aviv

  • Sheba - Medical Center

    Tel HaShomer

Other trials in Israel

Poland7 sites

  • Swietokrzyskie Centrum Onkologii

    Kielce

  • Wojewodzki Szpital Specjalistyczny im. L.Rydygiera

    Krakow

  • Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Regionalny Osrodek Onkologiczny

    Lodz

  • Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii

    Olsztyn

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opolskie Centrum Onkologii

    Opole

  • Wielkopolskie Centrum Onkologii

    Poznan

  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

    Warsaw

Other trials in Poland

Ukraine7 sites

  • Chernovtsy Regional Oncology Center

    Chernivtsy

  • Kharkov Regional Clinical Oncology Dispensary

    Kharkiv

  • Institute of Oncology of AMS of Ukraine

    Kiev

  • Institute of Otolaryngology

    Kiev

  • Volyn Regional Oncology Dispensary

    Lutsk

  • Uzhgorod National University

    Uzhhorod

  • Zaporozhye Regional Clinical Oncology Dispensary

    Zaporizhzhya

Other trials in Ukraine

Spain6 sites

  • Hospital Santa Creu i Sant Pau

    Barcelona

  • Hospital Vall d'Hebron

    Barcelona

  • Hospital 12 de Octubre

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Provincial de Pontevedra

    Pontevedra

  • Hospital Universitario de Salamanca

    Salamanca, Castilla Y León

Other trials in Spain

Mexico5 sites

  • Hospital Clínica del Parque

    Chihuahua, Chih.

  • Centro Anticanceroso de la Cruz Roja Mexicana de Mérida

    Mérida

  • OCA Hospital

    Monterrey N.L.

  • Hospital Central "Dr. Ignacio Morones Prieto"

    San Luis Potosi, SLP

  • Hospital "Dr. Angel Leaño"

    Zapopan, Jalisco

Other trials in Mexico

Slovakia5 sites

  • Teaching Hospital with Policlinic of F. D. Roosevelt Department of Otorhinolaryngology and Surgery

    Banská Bystrica

  • Oncology Institute of St. Elisabeth Clinic of Stomatology and Maxillofacial Surgery

    Bratislava

  • Teaching Hospital with Policlinic Bratislava 1st Clinic of Otorhinolaryngology

    Bratislava

  • Vychodoslovensky oncologicky ustav a.s.

    Košice

  • Teaching Hospital with Policlinic Nové Zámky Clinic of Otorhinolaryngology

    Nové Zámky

Other trials in Slovakia

Hungary4 sites

  • Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Fej-nyaksebeszet

    Budapest

  • Orszagos Onkologiai Intezet

    Budapest

  • Debreceni Egyetem OEC, Onkologiai Tanszek

    Debrecen

  • Petz Aladar Megyei Korhaz, Ful-orr-gege, Fej, Nyak Sebeszet

    Győr

Other trials in Hungary

Croatia3 sites

  • Clinical Hospital "Sestre milosrdnice"

    Zagreb

  • Clinical Hospital Centre Zagreb, Clinic for ENT, Department for Head and Neck Surgery

    Zagreb

  • Universtity Hospital for Tumors, Department for Head and Neck Surgery

    Zagreb

Other trials in Croatia

France3 sites

  • Centre Georges-Francois Leclerc

    Dijon

  • Clinique Guillaume Le Conquerant

    Le Havre

  • Centre Régional de Lutte contre le Cancer Val d'Aurelle

    Montpellier

Other trials in France

Italy3 sites

  • Azienda Ospedaliera San Gerardo

    Monza

  • IRCCS Policlinico San Matteo

    Pavia

  • Azienda Ospedaliera Pisana

    Pisa

Other trials in Italy

United Kingdom3 sites

  • University Hospital Aintree

    Liverpool

  • Royal Marsden Hospital

    London

  • Christie Hospital

    Manchester

Other trials in United Kingdom

Romania2 sites

  • "Prof. Dr. I. Chiricuta" Institute of Oncology Medical Oncology and Radiotherapy II Department

    Cluj-Napoca

  • Oradea Clinical County Hospital Department of Medical Oncology

    Oradea

Other trials in Romania

Serbia2 sites

  • Institute for Oncology and Radiology of Serbia

    Belgrade

  • Military Medical Academy (MMA) Clinic for Maxillofacial Surgery

    Belgrade

Other trials in Serbia

About this study

Official title: A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease

The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.

Read the detailed description

Head and neck cancer is a general description of a disease that includes several types of soft tissue carcinomas that develop in the head and neck regions.

Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion molecule (Ep-CAM) that is highly expressed on squamous cell carcinomas of the head and neck (SCCHN). Proxinium is administered via intratumoural injection.

The primary objective of the study is to compare the overall survival time for patients treated with intratumourally injected Proxinium plus BSC versus BSC alone. Secondary objectives of the study include comparison of locoregional tumour control, local progression-free survival, symptomatic benefit and safety profile in patients who receive Proxinium plus BSC versus patients who receive BSC

Being tested
Proxinium
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell, Head and Neck Neoplasms, Mouth Neoplasms

What participants receive

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

  • ProxiniumDrug

    700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression

Study groups in NCT00412776
Study groupRoleWhat they receive
1ExperimentalProxinium plus Best Supportive Care
Receives: Drug: Proxinium
2No interventionBest Supportive Care

What is being measured

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

  1. Survival

    Measured: Death or 12 months from the date that the last patient required for efficacy analysis has been randomized

Secondary outcomes (1)

  1. Tumour response, safety and quality of life

    Measured: Death or 12 months from the date that the last patient required for efficacy analysis has been randomized

Timeline

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

  1. First posted18 Dec 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionApr 2008
  4. Study completionApr 2008

Why it stopped: Corporate reasons unrelated to safety and 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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00412776
Sponsor's protocol ID
VB4-845-01-IIIA
Status last verified
Dec 2015
First submitted
14 Dec 2006
Last updated
23 Dec 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Proxinium in people with Carcinoma, Squamous Cell of Head and Neck and Carcinoma, Squamous Cell, run by Sesen Bio, Inc. at 122 sites in 18 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 18 inclusion and 9 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 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in Brazil, India, Russia, Germany, Argentina and 13 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study was stopped early (reason given: Corporate reasons unrelated to safety and efficacy). Results are not available in the source record.

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?

Survival (time frame: Death or 12 months from the date that the last patient required for efficacy analysis has been randomized). 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 NCT00412776.

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 23 Dec 2015.

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