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 |
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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