- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01244438
Study of FP-1039 in Subjects With Endometrial Cancers
December 9, 2021 updated by: Five Prime Therapeutics, Inc.
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion criteria for study participation:
- 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.
Exclusion Criteria for study participation:
- 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.
- No exclusionary medical history as described per the protocol.
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.
- 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.
- Unable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FP-1039
|
FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: up to 1 year
|
To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations
|
up to 1 year
|
Progression-free survival
Time Frame: 6 months
|
To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: up to 1 year
|
To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer
|
up to 1 year
|
Pharmacokinetics of Plasma
Time Frame: up to 1 year
|
To determine pharmacokinetics (PK) plasma concentration at specified times
|
up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Harold Keer, MD, PhD, Five Prime Therapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Anticipated)
June 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
November 17, 2010
First Submitted That Met QC Criteria
November 18, 2010
First Posted (Estimate)
November 19, 2010
Study Record Updates
Last Update Posted (Actual)
December 13, 2021
Last Update Submitted That Met QC Criteria
December 9, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP1039-002
- 2010-024344-15 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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