NCT00318370

Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy

A Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Morphotek · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.

Detailed description

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) either alone or in combination with other drugs. MORAb-003 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 MORAb-003 can work either as a single agent 1. to treat a CA125-only relapse, or 2. in combination with standard platinum and taxane chemotherapy to treat a symptomatic relapse, and 3. to prolong a second response to chemotherapy.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Neoplasms

Interventions

Type	Name	Description
DRUG	Farletuzumab	Weekly Farletuzumab infusions Dose dependent on dosing group
DRUG	Chemo Plus Far	Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-02-01
• Completion: 2010-06-01
• First posted: 2006-04-26
• Last updated: 2015-09-09
• Results posted: 2012-02-15

Locations

20 sites across 2 countries: United States, Germany