At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
Topotecan +1 moredrug
Likely dose
CCI-779 (temsirolimus) 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies
In Brief
A Phase 1 clinical trial evaluating Topotecan and CCI-779 (temsirolimus) for Genital Neoplasms, Female. Completed, enrolled 15 participants across 1 site.
Detailed Summary
The aim of the trial is to determine the recommended phase II dose of weekly intravenous topotecan in combination with a fixed dose (25 mg or 15 mg) of weekly intravenous temsirolimus in patients with and without prior pelvic radiation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenital Neoplasms, Female
CountriesUnited States
CollaboratorsWyeth is now a wholly owned subsidiary of Pfizer
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedAug 2007
Primary CompletionSep 2009
Study CompletionDec 2010
TodayJul 2026
First PostedAug 31, 2007
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.8 years ago
Interventions
Topotecandrug
Weekly doses via IV infusion. Dose will be assigned based on time of study entry.
CCI-779 (temsirolimus)drug
Weekly 25mg dose via IV infusion.