Study of FP-1039 in Subjects With Endometrial Cancers
- Conditions
- Endometrial Cancers With FGFR2 Mutations
- Interventions
- Drug: FP-1039
- Registration Number
- NCT01244438
- Lead Sponsor
- Five Prime Therapeutics, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FP-1039 FP-1039 FP-1039
- Primary Outcome Measures
Name Time Method Response rate up to 1 year To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations
Progression-free survival 6 months To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations
- Secondary Outcome Measures
Name Time Method Safety and tolerability up to 1 year To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer
Pharmacokinetics of Plasma up to 1 year To determine pharmacokinetics (PK) plasma concentration at specified times