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Study of FP-1039 in Subjects With Endometrial Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01244438
Recruitment Status : Withdrawn (Study FP1039-002 was not feasible. The original assumption was at least 5% of patients screened would qualify, but after screening 70 patients, none qualified.)
First Posted : November 19, 2010
Last Update Posted : March 12, 2012
Worldwide Clinical Trials
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancers With FGFR2 Mutations Drug: FP-1039 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: FP-1039
Drug: FP-1039
FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week.

Primary Outcome Measures :
  1. Response rate [ Time Frame: up to 1 year ]
    To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations

  2. Progression-free survival [ Time Frame: 6 months ]
    To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: up to 1 year ]
    To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer

  2. Pharmacokinetics of Plasma [ Time Frame: up to 1 year ]
    To determine pharmacokinetics (PK) plasma concentration at specified times

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01244438

Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Worldwide Clinical Trials
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Study Chair: Harold Keer, MD, PhD Five Prime Therapeutics, Inc.
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Responsible Party: Five Prime Therapeutics, Inc. Identifier: NCT01244438    
Other Study ID Numbers: FP1039-002
2010-024344-15 ( EudraCT Number )
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012
Keywords provided by Five Prime Therapeutics, Inc.:
endometrial cancer
FGFR2 mutations
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases