CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
RAD001drug
Likely dose
RAD001 10 mg orally dailyAI-extracted
Key inclusion· 4
  • Histologically confirmed progressive or recurrent endometrial cancer with endometrioid or mixed endometrioid component histology (any grade)
  • Failed no more than two prior chemotherapies for recurrent disease (chemosensitizing radiation does not count)
  • Measurable disease by physical examination or imaging (ascites and pleural effusions do not qualify)
  • Zubrod performance status 0, 1, or 2
Key exclusion· 8
  • Prior treatment with RAD001 or any mTOR inhibitor
  • Serous carcinoma, mixed malignant mullerian tumors (MMMT), or uterine sarcoma components
  • Isolated recurrence amenable to curative radiation or surgery
  • History of myocardial infarction within 6 months or congestive heart failure requiring therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00087685
NCT00087685Phase 2Completed

A Phase II Study of RAD001 in Patients With Recurrent Endometrial Cancer

M.D. Anderson Cancer Center·interventional·Posted Jul 14, 2004·Updated May 1, 2025

In Brief

A Phase 2 clinical trial evaluating RAD001 for Endometrial Cancer. Completed, enrolled 35 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer. The safety of this drug will also be studied. Objectives: Primary Objective: 1\. To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial cancer. Secondary Objective: 1. To determine the nature and degree of toxicity of RAD001 in this cohort of patients. 2. To characterize, in pre- and post- treatment tumor samples, when available, expression levels of total and phosphorylated mTOR (mammalian "target of rapamycin") as well as relevant upstream and downstream signaling components (optional).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2004
Enrollment StartJun 1, 2004
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 22.0 years ago

Interventions

RAD001drug

10 mg by mouth Daily