NCT01244438

Study of FP-1039 in Subjects With Endometrial Cancers

An Open-Label Phase 2 Pilot Study Evaluating the Activity and Safety of FP 1039 in Subjects With Advanced and/or Recurrent Endometrial Cancers With Specific FGFR2 Mutations

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Five Prime Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, non-randomized, single arm study to assess the safety, tolerability, and pharmacokinetics of FP-1039 given by weekly intravenous (IV) administrations in advanced endometrial cancer patients with FGFR2-specific mutations. FP-1039 will be dosed weekly starting at a dose of up to 16 mg/kg.

Detailed description

FP-1039 will be administered intravenously over 30 minutes once a week. All enrolled subjects will be monitored for the occurrence of unacceptable toxicity. Subjects with no evidence of disease progression or unacceptable toxicity after 4 doses of FP-1039 may continue to receive weekly treatment provided there continues to be no evidence of disease progression or unacceptable toxicity. Dosing will be discontinued if a subject has evidence of disease progression. Disease will be assessed approximately every 2 months.

Conditions

• Endometrial Cancers With FGFR2 Mutations

Interventions

Type	Name	Description
DRUG	FP-1039	FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2010-11-19
• Last updated: 2021-12-13