drugset / Trial / NCT00523432
A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies
Phase 1
Completed
15 enrolled
University of Chicago
Wyeth is now a wholly owned subsidiary of Pfizer · collab
Non-randomizedFactorialOpen-labelTreatment
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.
Timeline
- Start
- 2007-08
- Primary completion
- 2009-09
- Completion
- 2010-12
Publications
- Results Temkin SM, Yamada SD, Fleming GF. A phase I study of weekly temsirolimus and topotecan in the treatment of advanced and/or recurrent gynecologic malignancies. Gynecol Oncol. 2010 Jun;117(3):473-6. doi: 10.1016/j.ygyno.2010.02.022. Epub 2010 Mar 28.
- Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temsirolimus | Small molecule | 15 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 25 mg | Intravenous |
| Subject | Topotecan | Small molecule | 1 mg/m2 | Intravenous |