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
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
- 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