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

July 15, 2014 updated by: Morphotek

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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.
Other Names:
  • Carboplatin
  • PLD
  • Farletuzumab (MORAb-003)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: Every 2 months
Every 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morphotek

Investigators

  • Study Director: Susan Weil, MD, Morphotek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MORAb-003-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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