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


Phase 1
18 Years
N/A
Not Enrolling
Female
Epithelial Ovarian Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.

Outcome Time Frame:

At all study visits.

Safety Issue:

Yes

Principal Investigator

Susan Weil, MD

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

MORAb-003-005

NCT ID:

NCT01004380

Start Date:

November 2009

Completion Date:

October 2012

Related Keywords:

  • Epithelial Ovarian Cancer
  • Epithelial Ovarian Cancer
  • Ovarian Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Chattanooga GYN OncologyChattanooga, Tennessee  37403
Schwartz Gynecologic OncologyBrightwaters, New York  11718
University of Alabama at Birmingham Medical CenterBirmingham, Alabama  35233
International Beneficence Clinical Research, LLCHarlingen, Texas  78550