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Clinical Trials/NCT01004380
NCT01004380CompletedPhase 1

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

Morphotek5 sites in 1 country15 target enrollmentStarted: November 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Morphotek
Enrollment
15
Locations
5
Primary Endpoint
To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Farletuzumab

Experimental

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

Intervention: Farletuzumab, Carboplatin, and PLD (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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.(Every 2 months)

Investigators

Sponsor
Morphotek
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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