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A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies

NCT00523432 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-09-05

No results posted yet for this study

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.

Conditions

  • Genital Neoplasms, Female

Interventions

DRUG

Topotecan

Weekly doses via IV infusion. Dose will be assigned based on time of study entry.

DRUG

CCI-779 (temsirolimus)

Weekly 25mg dose via IV infusion.

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Gini Fleming, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-09-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00523432 on ClinicalTrials.gov