Study of FP-1039 in Subjects With Endometrial Cancers

NCT01244438 | Withdrawn Phase 2 DMC

• 2 other identifiers: FP1039-0022010-024344-15
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrial Cancers With FGFR2 Mutations

Keywords

endometrial cancer; FGFR2 mutations

Outcome Measures

Primary Outcomes (2)

• Response rate

  To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations

  up to 1 year

• Progression-free survival

  To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations

  6 months

Secondary Outcomes (2)

• Safety and tolerability

  up to 1 year

• Pharmacokinetics of Plasma

  up to 1 year

Study Arms (1)

FP-1039

EXPERIMENTAL

FP-1039

Drug: FP-1039

Interventions

FP-1039 DRUG

FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week.

FP-1039

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Five Prime Therapeutics, Inc.: lead
• Worldwide Clinical Trials: collaborator

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

FP-1039

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Harold Keer, MD, PhD

  Five Prime Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 13, 2021

Record last verified: 2021-12