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

Morphotek

Status and phase: Terminated; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Farletuzumab; Drug: Farletuzumab-matched placebo; Drug: Taxane; Drug: Carboplatin

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00849667

2008-005872-29 (EudraCT Number)

MORAb003-004

Details and patient eligibility

About

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.

Enrollment: 1,100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,100 participants in 3 patient groups, including a placebo group

Farletuzumab (1.25 mg/kg)

Active Comparator group

Description:

Participants 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.

Treatment:

Drug: Carboplatin

Drug: Taxane

Drug: Farletuzumab

Farletuzumab (2.5 mg/kg)

Active Comparator group

Description:

Participants 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.

Treatment:

Drug: Carboplatin

Drug: Taxane

Drug: Farletuzumab

Placebo

Placebo Comparator group

Description:

Participants 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.

Treatment:

Drug: Carboplatin

Drug: Taxane

Drug: Farletuzumab-matched placebo