Study of FP-1039 in Subjects With Endometrial Cancers



Status:Archived
Conditions:Cervical Cancer, Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:January 2011
End Date:December 2012

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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.


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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Oklahoma City, OK
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