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

NCT ID: NCT01004380

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-10-31

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.

Conditions

Epithelial Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Farletuzumab

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

Group Type: EXPERIMENTAL

Farletuzumab, Carboplatin, and PLD

Intervention Type: DRUG

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.

Interventions

Farletuzumab, Carboplatin, and PLD

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.

Intervention Type: DRUG

Other Intervention Names

Farletuzumab (MORAb-003); Carboplatin; PLD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Morphotek

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Weil, MD

Role: STUDY_DIRECTOR

Morphotek

Locations

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, United States

Johns Hopkins University

Baltimore, Maryland, United States

Schwartz Gynecologic Oncology

Brightwaters, New York, United States

Chattanooga GYN Oncology

Chattanooga, Tennessee, United States

International Beneficence Clinical Research, LLC

Harlingen, Texas, United States

Countries

United States

Other Identifiers

MORAb-003-005

Identifier Type: -

Identifier Source: org_study_id