Endometrial Cancers With FGFR2 MutationsPhase 2NCT01244438
Study of FP-1039 in Subjects With Endometrial Cancers
A Phase 2 study testing FP-1039 in people with Endometrial Cancers With FGFR2 Mutations, run by Five Prime Therapeutics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancers With FGFR2 Mutations
- What is being tested?
- FP-1039
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
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
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.
Read the 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.
- Conditions
- Endometrial Cancers With FGFR2 Mutations
- Being tested
- FP-1039
- Keywords
- endometrial cancer, FGFR2 mutations
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP-1039Drug
FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week.
| Study group | Role | What they receive |
|---|---|---|
| FP-1039 | Experimental | FP-1039 Receives: Drug: FP-1039 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations
Measured: up to 1 year
Progression-free survival
To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations
Measured: 6 months
Secondary outcomes (2)
Safety and tolerability
To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer
Measured: up to 1 year
Pharmacokinetics of Plasma
To determine pharmacokinetics (PK) plasma concentration at specified times
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Cancers With FGFR2 MutationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Five Prime Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Harold Keer, MD, PhD, Study chair, Five Prime Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244438
- Sponsor's protocol ID
- FP1039-002
- Other IDs
- 2010-024344-15
- Status last verified
- Dec 2021
- First submitted
- 17 Nov 2010
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01244438
- Acronym / sponsor ID
- FP1039-002
- Conditions
- Endometrial Cancers With FGFR2 Mutations
- Keywords
- endometrial cancer, FGFR2 mutations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Five Prime Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FP-1039 | Experimental | Drug: FP-1039FP-1039 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- Prior treatment with an inhibitor of the FGF/FGFR pathway
- Prior treatment with any of the following:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FP-1039FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week. | Drug | FP-1039 |
Primary outcome
Response rate
Time frame: up to 1 year
To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations
Progression-free survival
Time frame: 6 months
To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations
2 secondary outcomes
Safety and tolerability
Time frame: up to 1 year
Pharmacokinetics of Plasma
Time frame: up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold Keer, MD, PhD study chair
Five Prime Therapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FP-1039 in people with Endometrial Cancers With FGFR2 Mutations, run by Five Prime Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.