Ovarian Cancer Clinical Trial

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

Summary

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

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Full 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

is safe, or
to assess the potential drug-drug interaction, and
to prolong response to chemotherapy.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT01004380

Recruitment Status:

Completed

Sponsor:

Morphotek

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There are 5 Locations for this study

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University of Alabama at Birmingham Medical Center
Birmingham Alabama, 35293, United States
Johns Hopkins University
Baltimore Maryland, 21205, United States
Schwartz Gynecologic Oncology
Brightwaters New York, 11718, United States
Chattanooga GYN Oncology
Chattanooga Tennessee, 37403, United States
International Beneficence Clinical Research, LLC
Harlingen Texas, 78550, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT01004380

Recruitment Status:

Completed

Sponsor:


Morphotek

How clear is this clinincal trial information?

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