Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of FP-1039 in Subjects With Endometrial Cancers

This study has been withdrawn prior to enrollment.
(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.)
Sponsor:
Collaborator:
Worldwide Clinical Trials, LLC, St. Petersburg, Russia
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01244438
First received: November 17, 2010
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Endometrial Cancers With FGFR2 Mutations
Drug: FP-1039
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Five Prime Therapeutics, Inc.:

Primary Outcome Measures:
  • Response rate [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations

  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer

  • Pharmacokinetics of Plasma [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    To determine pharmacokinetics (PK) plasma concentration at specified times


Enrollment: 0
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FP-1039
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244438

Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Worldwide Clinical Trials, LLC, St. Petersburg, Russia
Investigators
Study Chair: Harold Keer, MD, PhD Five Prime Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01244438     History of Changes
Other Study ID Numbers: FP1039-002, 2010-024344-15
Study First Received: November 17, 2010
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Five Prime Therapeutics, Inc.:
endometrial cancer
FGFR2 mutations

Additional relevant MeSH terms:
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014