NCT01016054

A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer

A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.

Detailed description

All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.

Conditions

• Carcinoma
• Ovarian Cancer
• Ovarian Diseases
• Ovarian Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	AGS-8M4	IV infusion
DRUG	Pegylated liposomal doxorubicin (PLD)	IV infusion
DRUG	gemcitabine	IV infusion
DRUG	carboplatin	IV infusion

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-11-18
• Last updated: 2013-02-27

Locations

1 site across 1 country: United States