Trial Search Results

Study of FP-1039 in Subjects With Endometrial Cancers

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Collaborator: Worldwide Clinical Trials

Stanford Investigator(s):


  • Drug: FP-1039


Phase 2


Inclusion criteria for study participation:

   1. Evidence of histologically or cytologically proven metastatic or locally advanced
   unresectable endometrial cancer bearing either the S252W or the P243R FGFR2 mutation.

   2. Female at least 18 years of age

   3. Performance status ≤ 1 on the ECOG Performance Status Scale

   4. Adequate cardiac function e.g., NYHA Class I or II

   5. Estimated life expectancy of at least 16 weeks

   6. Measurable or evaluable disease by physical or radiologic examination

   7. Must have recovered from the adverse effects of prior therapy at the time of
   enrollment to ≤ Grade 1 (excluding alopecia)

   8. Meets laboratory criteria as specified per protocol.

Exclusion Criteria for study participation:

   1. Prior treatment with an inhibitor of the FGF/FGFR pathway

   2. 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

   3. Known hypersensitivity to the components of FP-1039

   4. Current anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤
   1mg/day is permitted)

   5. PT/INR and/or PTT test results at screening that are above 1.3 x the laboratory ULN.

   6. No exclusionary medical history as described per the protocol.

   7. 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)

   8. History of organ, bone marrow, or stem cell transplantation

   9. Pregnant or breast feeding

10. 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.

11. 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.

12. Unable or unwilling to abide by the study protocol or cooperate fully with the
   Investigator or designee

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
Not Recruiting