Study of the Weekly Oral RAD001 in Combination With Oral Topotecan in Patients With Advanced or Recurrent Endometrial Cancers

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Yale University

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

Endometrial cancer is the most common malignancy of the female reproductive tract. The majority of patients with endometrial cancer are diagnosed at an early stage and cured with surgery with or without adjuvant radiotherapy. However, a significant number of patients present with metastatic disease outside of the pelvis or develop recurrent disease after primary therapy. mTOR inhibitors have been shown to be promising agents in reducing tumor growth in vitro and in vivo, in several solid cancers. Inhibitors of mTOR are primarily cytostatic in cancer cells; combination therapy with cytotoxic chemotherapeutics and other biologic agents may prove to be the most advantageous use of these drugs. mTOR inhibition with a rapamycin analogue demonstrated in vitro antiproliferative activity on endometrial AN3 CA and HEC-1-A tumor cells, and this inhibition of proliferation was found to be concentration dependent. Topotecan is an active agent in the treatment of advanced and recurrent endometrial cancers.

Research Team

Maysa Abu-Khalaf, M.D.

Principal Investigator

Yale University

Eligibility Criteria

Inclusion Criteria

Patients must have histologically-confirmed advanced or recurrent endometrial cancer

Patients must be refractory to standard therapy or for which no curative standard therapy exists, to be considered. Metastatic disease, if present, should not be progressing so as to require palliative treatment within 4 weeks of enrollment based on clinical assessment by the investigator.

Development of new lesions or an increase in preexisting lesions on bone scintigraphy, CT, MRI or by physical examination. Patients in whom the sole criterion for progression is an increase in a biochemical marker, e.g., carcinoembryonic antigen (CEA), or an increase in symptoms, are not eligible.

Treatment Details

Interventions

• RAD001 (mTOR inhibitor)
• Topotecan (Topoisomerase I inhibitor)

Participant Groups

Group I: 1 Experimental Treatment 2 Interventions

Daily oral RAD001 for 21 days in combination with oral topotecan on days 1-5 of a 21 day cycle

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania