Status:
WITHDRAWN
Study of FP-1039 in Subjects With Endometrial Cancers
Lead Sponsor:
Five Prime Therapeutics, Inc.
Collaborating Sponsors:
Worldwide Clinical Trials
Conditions:
Endometrial Cancers With FGFR2 Mutations
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 pati...
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 progre...
Eligibility Criteria
Inclusion
- Inclusion criteria for study participation:
- Evidence of histologically or cytologically proven metastatic or locally advanced unresectable endometrial cancer bearing either the S252W or the P243R FGFR2 mutation.
- Female at least 18 years of age
- Performance status ≤ 1 on the ECOG Performance Status Scale
- Adequate cardiac function e.g., NYHA Class I or II
- Estimated life expectancy of at least 16 weeks
- Measurable or evaluable disease by physical or radiologic examination
- Must have recovered from the adverse effects of prior therapy at the time of enrollment to ≤ Grade 1 (excluding alopecia)
- Meets laboratory criteria as specified per protocol.
- Exclusion Criteria for study participation:
- Prior treatment with an inhibitor of the FGF/FGFR pathway
- Prior treatment with any of the following:
- Cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (antibodies, immune modulators, cytokines) within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks prior to the scheduled first dose of FP-1039
- A small-molecule kinase inhibitor (including investigational small-molecule kinase inhibitors) within 14 days (or 5 half lives of the drug or active metabolites) of the scheduled first dose of FP-1039
- Any other investigational therapy within 28 days of the first scheduled dose of FP-1039 Note: Any eligibility questions related to prior therapies including the timing from prior therapies should be discussed and a decision agreed on by the Investigator and the Sponsor in writing prior to the subject entering the study
- Known hypersensitivity to the components of FP-1039
- Current anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1mg/day is permitted)
- PT/INR and/or PTT test results at screening that are above 1.3 x the laboratory ULN.
- No exclusionary medical history as described per the protocol.
- Presence of any of the following conditions:
- Luminal intestinal cancers and/or abdominal carcinomatosis
- History of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment
- Other potential risk factors for gastrointestinal perforation (i.e., acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction)
- History of organ, bone marrow, or stem cell transplantation
- Pregnant or breast feeding
- Clinically apparent CNS metastases or carcinomatous meningitis Note: Subjects with CNS metastases who have completed a course of radiotherapy and who have been on a stable dose of glucocorticoids for at least 4 weeks are eligible.
- Uncontrolled intercurrent illness including but not limited to an active infection, hypertension, psychiatric, or substance abuse disorders that would preclude consent, limit compliance with study requirements, or confound safety interpretation.
- Unable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01244438
Start Date
January 1 2011
End Date
December 1 2012
Last Update
December 13 2021
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