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Platinum-Sensitive Ovarian Cancer in First RelapsePhase 2NCT02289950

A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer

A Phase 2 study testing Farletuzumab in people with Platinum-Sensitive Ovarian Cancer in First Relapse, run by Eisai Inc. at 68 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Farletuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
332 participants
Where
68 sitesin 7 countries
Study dates
19 Mar 2015to 13 Aug 2020
Phase
Phase 2
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

  • Female subjects who are at least 18 years of age at the time of informed consent
  • CA125 less than or equal to 3 x upper limit of normal (ULN) [105 units per millilitre (U/mL)] confirmed within 2 weeks of randomization using a centralized laboratory assay
  • A histologically confirmed diagnosis of high-grade serous epithelial ovarian cancer including primary peritoneal and fallopian tube malignancies; all other histologies, including mixed histology, are excluded
  • Have been treated with debulking surgery and a first-line platinum-based chemotherapy regimen
  • Maintenance therapy during the first platinum-free interval is allowed; however, the last dose must have been at least 21 days prior to Randomization.
  • Must be in a first relapse and have evaluable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan, according to RECIST 1.1 (subjects with measurable disease per RECIST 1.1 or radiographically visible and evaluable disease). Subjects with only ascites or pleural effusion are excluded.
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  • Must have relapsed radiographically between 6 months and 36 months of completion of first-line platinum chemotherapy
  • Must be a candidate for treatment with either carboplatin plus paclitaxel or carboplatin plus PLD with no medical contraindications present as outlined in the product labels for the selected regimen to be used in this study
  • Have a life expectancy of at least 6 months, as estimated by the investigator
  • Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Randomization
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Subjects being enrolled to receive paclitaxel plus carboplatin treatment must have neuropathic function (sensory and motor less than or equal to Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (2010)
  • Laboratory results within the 2 weeks prior to Randomization must be as follows:
  • Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
  • Platelet count greater than or equal to 100 x 10^9/L
  • Hemoglobin greater than or equal to 9 g/dL
  • Creatinine less than 1.5 x ULN (CTCAE Grade 1)
  • Bilirubin less than 1.5 x ULN (CTCAE Grade 1)
  • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) less than 3 x ULN
  • Alkaline Phosphatase less than 2.5 x ULN (CTCAE Grade 1)
  • Baseline albumin greater than or equal to Lower Limit of Normal
  • Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. All females will be considered to be of childbearing potential unless they are postmenopausal (eg, amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). If a patient of childbearing potential is neither surgically sterile nor postmenopausal, a highly-effective contraceptive method (ie, a method that can achieve a failure rate of less than 1 percent (%) per year when used consistently and correctly) must start either before or at Screening and continue throughout the entire study period and for 6 months after the last dose of Test Article is administered. Pregnant and/or lactating females are excluded

Who cannot join

  • Known central nervous system (CNS) tumor involvement
  • Evidence of other active invasive malignancy requiring treatment other than surgery in the past 3 years
  • Clinically significant heart disease (eg, congestive heart failure of New York Heart Association Class 3 or 4 angina, not well controlled by medication, or myocardial infarction within 6 months)
  • Electrocardiogram (ECG) demonstrating clinically significant arrhythmias that are not adequately medically managed (Note: subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible)
  • Active serious systemic disease, including active bacterial or fungal infection
  • Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary.
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  • Other concurrent immunotherapy (eg, immunosuppressants or chronic use of systemic corticosteroids, with the exception that low-dose corticosteroids [50 mg/day prednisone or equivalent corticosteroid] are allowed; these should be discussed with the Medical Monitor)
  • Known allergic reaction to a prior monoclonal antibody therapy or have any documented Anti-Drug Antibody (ADA) response; additionally known allergic reaction to the concomitant chemotherapies selected by the investigator for planned treatment in this study unless desensitization is planned
  • Previous treatment with farletuzumab or other folate receptor targeting agents
  • Previous treatment with cancer vaccine therapy
  • For subjects being enrolled to receive PLD plus carboplatin, prior treatment with anthracyclines or anthracenodiones
  • Breast-feeding, pregnant, or likely to become pregnant during the study
  • Any medical or other condition that, in the opinion of the investigator, would preclude the subject's participation in a clinical study including medical contraindications as outlined in the product labels for the chemotherapies selected by the investigator for planned treatment in this study
  • Patients who have had secondary debulking surgery or any second line therapy
  • Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 x half-life for investigational drugs where the half-life is known) preceding informed consent

Trial locations and contacts

68 sites in 7 countries.

68 sites in 7 countries

United States35 sites

  • Study site

    Annandale, Virginia

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Boston, Massachusetts

  • Study site

    Centerville, Ohio

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Detroit, Michigan

  • Study site

    Grand Island, Nebraska

  • Study site

    Knoxville, Tennessee

  • Study site

    Lexington, Kentucky

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Miami, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    Miramar, Florida

  • Study site

    New York, New York

  • Study site

    Orange, California

  • Study site

    Orlando, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Roseville, California

  • Study site

    Sacramento, California

  • Study site

    Sarasota, Florida

  • Study site

    Savannah, Georgia

  • Study site

    Tampa, Florida

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Italy8 sites

  • Study site

    Avellino

  • Study site

    Bari, Apulia

  • Study site

    Bologna

  • Study site

    Milan

  • Study site

    Naples, Campania

  • Study site

    Naples

  • Study site

    Perugia

  • Study site

    Rome, Lazio

Other trials in Italy

Japan8 sites

  • Study site

    Chūōku

  • Study site

    Hidaka

  • Study site

    Kashiwa

  • Study site

    Kōtoku

  • Study site

    Kurume

  • Study site

    Matsuyama

  • Study site

    Minatoku

  • Study site

    SuntoGun

Other trials in Japan

Belgium6 sites

  • Study site

    Brussels, Brussels Capital

  • Study site

    Edegem, Antwerpen

  • Study site

    Ghent, Oost-Vlaanderen

  • Study site

    Hasselt, Limburg

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Germany5 sites

  • Study site

    Berlin

  • Study site

    Chemnitz, Saxony

  • Study site

    Dresden

  • Study site

    Essen

  • Study site

    Ulm, Baden-Wurttemberg

Other trials in Germany

Spain4 sites

  • Study site

    Córdoba, Córdoba

  • Study site

    Madrid

  • Study site

    Palma de Mallorca, Balearic Islands

  • Study site

    Sabadell

Other trials in Spain

United Kingdom2 sites

  • Study site

    London

  • Study site

    Plymouth, Devon

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Subjects With Low CA125 Platinum-Sensitive Ovarian Cancer

MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse.

Read the detailed description

Participants will be enrolled into 1 of 2 chemotherapy treatment arms at the investigator's discretion: carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), and then randomized in a 2:1 ratio to receive weekly farletuzumab 5 mg/kg or placebo (ie, Test Article). All participants will receive a loading dose for the first 2 weeks of 10 mg/kg Test Article (farletuzumab or placebo). Participants will be stratified at randomization by individual chemotherapy treatment regimen (targeted 1:1 ratio) and platinum-free interval following first-line therapy (6 to 12 months vs greater than 12 to 36 months).

Being tested
Farletuzumab, Placebo
Keywords
Ovarian Cancer in in first relapse, Platinum-Sensitive

What participants receive

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

  • FarletuzumabDrug

    Farletuzumab will be administered intravenously (IV) weekly

  • PlaceboDrug

    Placebo will be administered intravenously (IV) weekly

Study groups in NCT02289950
Study groupRoleWhat they receive
FarletuzumabExperimentalAll participants will receive a loading dose for the first 2 weeks of 10 milligram per kilogram (mg/kg) farletuzumab, followed by 5 mg/kg weekly farletuzumab administered intravenously (IV).
Receives: Drug: Farletuzumab
PlaceboPlacebo comparatorAll subjects will receive placebo weekly, administered intravenously (IV).
Receives: Drug: 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 of a participant to the date of first observation of progression or date of death, whatever the cause. PFS was assessed based on the investigators' assessments utilizing Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Disease progression (PD) was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.

    Measured: From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    OS was defined as the time from the date of randomization until the date of death. Participants were censored at the date of last known to be alive. OS was analyzed using Kaplan-Meier method.

    Measured: From the date of randomization until the date of death (up to approximately 5 years 5 months)

  2. Number of Participants With Best Overall Response (BOR)

    BOR was defined as the best response of complete response (CR) or partial response (PR) or stable disease (SD) for greater than or equal to(>=)6 months recorded from the start of the treatment until PD or death, whichever occurred first based on investigator assessment per RECIST v1.1. CR:disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than(<)10 mm. PR:at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as at least 20% increase (including an absolute increase of at least 5mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

    Measured: From first dose of study drug (Baseline) up to approximately 5 years 5 months

  3. Time to Tumor Response (TTR)

    TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.

    Measured: From the date of randomization until date of first observation of response (CR or PR) up to approximately 5 years 5 months

  4. Duration of Response (DOR)

    DOR was defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression based on the investigator's assessment utilizing RECIST 1.1, or date of death, whatever the cause. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30 % decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

    Measured: From date of the first observation of CR or PR until the date of first observation of progression or date of death up to approximately 5 years 5 months

  5. Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval

    Percentage of participants achieving each second platinum-free interval (<6 months, 6-12 months, greater than [>] 12-36 months, and >36 months) stratified by first platinum-free interval (6 to 12 months and >12 to 36 months) was reported. First platinum-free interval was defined as the date of completion of previous platinum-based chemotherapy until the date of first relapse (that is, first observation of progression). The date of first relapse was the progression date. Second platinum-free interval was defined as the date of completion of platinum-based chemotherapy (last dosing date) during the study until the date of progression or death (or censoring, if applicable).

    Measured: From the date of randomization to the date of first relapse (or first observation of progression/death) up to approximately 5 year 5 months

Timeline

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

  1. First posted13 Nov 2014 (estimated)
  2. Study start19 Mar 2015
  3. Primary completion31 May 2019
  4. Study completion13 Aug 2020

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02289950
Sponsor's protocol ID
MORAb-003-011
Status last verified
Aug 2021
First submitted
10 Nov 2014
Last updated
2 Sep 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Herzog TJ, Pignata S, Ghamande SA, Rubio MJ, Fujiwara K, Vulsteke C, Armstrong DK, Sehouli J, Coleman RL, Gabra H, Scambia G, Monk BJ, Arranz JA, Ushijima K, Hanna R, Zamagni C, Wenham RM, Gonzalez-Martin A, Slomovitz B, Jia Y, Ramsay L, Tewari KS, Weil SC, Vergote IB. Randomized phase II trial of farletuzumab plus chemotherapy versus placebo plus chemotherapy in low CA-125 platinum-sensitive ovarian cancer. Gynecol Oncol. 2023 Mar;170:300-308. doi: 10.1016/j.ygyno.2023.01.003. Epub 2023 Feb 7.

    PubMed 36758420

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Farletuzumab in people with Platinum-Sensitive Ovarian Cancer in First Relapse, run by Eisai Inc. at 68 sites in 7 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 22 inclusion and 15 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: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Italy, Japan, Belgium, Germany and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 2 Sep 2021). 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 PD, or date of death, whichever occurs first up to approximately 5 years 5 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 NCT02289950, which also lists 1 linked publication.

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 2 Sep 2021.

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