Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.

Detailed Description
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Farletuzumab (MORAb-003) is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) in combination with other drugs. Farletuzumab works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if the combination therapy of farletuzumab, carboplatin, and PLD is safe, or to assess the potential drug-drug interaction, and to prolong response to chemotherapy.

Official Title
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A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Drug: Farletuzumab, Carboplatin, and PLD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of epithelial ovarian cancer Must have measurable disease by CT or MRI scan Must have relapsed as defined by CA-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy Must have been treated with surgery and be a candidate for repeat carboplatin therapy Must have a normal cardiac ejection fraction at baseline Exclusion Criteria: Subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs <6 months from the last platinum therapy Subjects who have received other therapy to treat their ovarian cancer since last relapse Known central nervous system tumor involvement Evidence of other active invasive malignancy Clinically significant heart disease Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA Previous treatment with MORAb 003 (farletuzumab) Previous treatment with anthracyclines Clinical contraindications to use PLD

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Farletuzumab<br>2.5 mg/kg once weekly administered i.v. during the Combination treatment period and 7.5 mg/kg Q3W administered i.v. during the Maintenance period | Drug: Farletuzumab, Carboplatin, and PLD<br>* All subjects will receive approximately 6 cycles with carboplatin (AUC5-6) i.v. and PLD (30 mg/m2) i.v. on Day 1 of every 4-week Combination treatment cycle. In addition, subjects will also receive weekly farletuzumab at 2.5 mg/kg administered i.v. Following completion of the Combination treatment period (carboplatin/PLD/farletuzumab therapy),maintenance treatment with single agent farletuzumab will be administered once Q3W at 7.5 mg/kg until disease progression as defined by GCIG CA-125 (i.e., CA-125 is less than or equal to 2 × (ULN) documented on 2 occasions) or modified RECIST v.1.0 using CT or MRI.<br>* Other names: PLD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer. |  | At all study visits. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of farletuzumab in combination with carboplatin and PLD on best objective response rate, time to response, and duration of response by RECIST criteria. |  | Every 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epithelial Ovarian Cancer, Ovarian Cancer