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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01004380
First received: October 20, 2009
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Epithelial Ovarian Cancer
Drug: Farletuzumab, Carboplatin, and PLD
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: November 2009
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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:
    • Farletuzumab (MORAb-003)
    • Carboplatin
    • PLD
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004380

Locations
United States, Alabama
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States, 35293
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, New York
Schwartz Gynecologic Oncology
Brightwaters, New York, United States, 11718
United States, Tennessee
Chattanooga GYN Oncology
Chattanooga, Tennessee, United States, 37403
United States, Texas
International Beneficence Clinical Research, LLC
Harlingen, Texas, United States, 78550
Sponsors and Collaborators
Morphotek
Investigators
Study Director: Susan Weil, MD Morphotek, Inc.
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01004380     History of Changes
Other Study ID Numbers: MORAb-003-005
Study First Received: October 20, 2009
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Morphotek:
Epithelial Ovarian Cancer
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Doxorubicin
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014