Phase 2
N=35
RAD001 in Recurrent Endometrial Cancer Patients
Endometrial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00087685 ↗Enrolled (actual)
35
Serious AEs
71.4%
Results posted
Feb 2016
Primary outcome: Primary: Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD) — 0; 0; 14; 17 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RAD001 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD) |
0; 0; 14; 17 | — |
| PRIMARY Clinical Benefit Rate |
21 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed progressive or recurrent endometrial cancer (endometrioid or mixed with endometrioid component histology; any grade).
- Patients may have failed no more than two prior chemotherapies for the recurrent disease (does not include chemosensitizing radiation).
- All patients must have measurable disease. Measurable disease is defined as lesions that can be measured by physical examination or by means of imaging techniques. Ascites and pleural effusions are not considered measurable disease.
- Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of >/=1,500/Fl, a hemoglobin level of >/=9.0 gm/dL and a platelet count of >/=100,000/Fl.
- Patients must have an adequate renal function as documented by serum creatinine /= grade 2 hypercholesterolemia or hypertriglyceridaemia (fasting state), despite lipid lowering therapy should be excluded from entering the study.
- Patients currently taking any of the medications listed in Appendix A (Patients will be given a listing of these medications at the time of the informed consent).
- Known hypersensitivity to everolimus, sirolimus or excipients including hydroxytoluene, magnesium stearate, hydroxypropylmethyl-cellulose, crospovidone and lactulose.
Data sourced from ClinicalTrials.gov (NCT00087685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.