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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01244438
Other study ID # FP1039-002
Secondary ID 2010-024344-15
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date January 2011
Est. completion date December 2012

Study information

Verified date December 2021
Source Five Prime Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Five Prime Therapeutics, Inc. Worldwide Clinical Trials

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate To assess the response rate of advanced endometrial cancer patients bearing FGFR-specific mutations up to 1 year
Primary Progression-free survival To assess 6-month progression free survival of advanced endometrial cancer patients bearing FGFR-specific mutations 6 months
Secondary Safety and tolerability To evaluate the safety and tolerability of FP-1039 in subjects with advanced endometrial cancer up to 1 year
Secondary Pharmacokinetics of Plasma To determine pharmacokinetics (PK) plasma concentration at specified times up to 1 year