Ovarian Cancer Clinical Trial

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

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.

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Full 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).

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Eligibility Criteria

Inclusion Criteria:

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.
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

Exclusion Criteria:

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.
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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

332

Study ID:

NCT02289950

Recruitment Status:

Completed

Sponsor:

Eisai Inc.

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There is 1 Location for this study

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Phoenix Arizona, , United States

Los Angeles California, , United States

Orange California, , United States

Roseville California, , United States

Sacramento California, , United States

Aurora Colorado, , United States

Miami Florida, , United States

Miramar Florida, , United States

Orlando Florida, , United States

Sarasota Florida, , United States

Tampa Florida, , United States

Atlanta Georgia, , United States

Augusta Georgia, , United States

Savannah Georgia, , United States

Chicago Illinois, , United States

Lexington Kentucky, , United States

Louisville Kentucky, , United States

Baltimore Maryland, , United States

Boston Massachusetts, , United States

Detroit Michigan, , United States

Minneapolis Minnesota, , United States

Grand Island Nebraska, , United States

New York New York, , United States

Chapel Hill North Carolina, , United States

Charlotte North Carolina, , United States

Winston-Salem North Carolina, , United States

Centerville Ohio, , United States

Cincinnati Ohio, , United States

Cleveland Ohio, , United States

Columbus Ohio, , United States

Chattanooga Tennessee, , United States

Knoxville Tennessee, , United States

Austin Texas, , United States

Annandale Virginia, , United States

Charlottesville Virginia, , United States

Edegem Antwerpen, , Belgium

Brussels Bruxelles, , Belgium

Hasselt Limburg, , Belgium

Gent Oost-Vlaanderen, , Belgium

Leuven , , Belgium

Liege , , Belgium

Ulm Baden-Württemberg, , Germany

Chemnitz Sachsen, , Germany

Berlin , , Germany

Dresden , , Germany

Essen , , Germany

Napoli Campania, , Italy

Roma Lazio, , Italy

Bari Puglia, , Italy

Avellino , , Italy

Bologna , , Italy

Milano , , Italy

Napoli , , Italy

Perugia , , Italy

Chuo-Ku , , Japan

Hidaka-City , , Japan

Kashiwa-City , , Japan

Koto-Ku , , Japan

Kurume-City , , Japan

Matsuyama-City , , Japan

Minato-Ku , , Japan

SuntoGun , , Japan

Palma de Mallorca Baleares, , Spain

Cordoba Córdoba, , Spain

Madrid , , Spain

Sabadell , , Spain

Plymouth Devon, , United Kingdom

London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

332

Study ID:

NCT02289950

Recruitment Status:

Completed

Sponsor:


Eisai Inc.

How clear is this clinincal trial information?

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