NCT01004380

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Morphotek · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-08-01
• Completion: 2012-10-01
• First posted: 2009-10-29
• Last updated: 2014-07-17

Locations

5 sites across 1 country: United States