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

Phase 1

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Drug: Farletuzumab, Carboplatin, and PLD

• Registration Number: NCT01004380
• Lead Sponsor: Morphotek

Brief Summary

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

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

1. is safe, or

2. to assess the potential drug-drug interaction, and

3. to prolong response to chemotherapy.

Study Timeline

• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Study Start: 2009-11
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Farletuzumab	Farletuzumab, Carboplatin, and PLD	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Schwartz Gynecologic Oncology; 🇺🇸 Brightwaters, New York, United States

International Beneficence Clinical Research, LLC; 🇺🇸 Harlingen, Texas, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Chattanooga GYN Oncology; 🇺🇸 Chattanooga, Tennessee, United States

University of Alabama at Birmingham Medical Center; 🇺🇸 Birmingham, Alabama, United States