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
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Primary Endpoint
- Response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
FP-1039
FP-1039
Intervention: FP-1039 (Drug)
Outcomes
Primary Outcomes
Response rate
Time Frame: up to 1 year
To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations
Progression-free survival
Time Frame: 6 months
To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations
Secondary Outcomes
- Safety and tolerability(up to 1 year)
- Pharmacokinetics of Plasma(up to 1 year)