Free Mesothelioma Information Packet

Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity

Sponsored by:Memorial Sloan Kettering Cancer Center
Information provided:Memorial Sloan Kettering Cancer Center Identifier:NCT01024946


For patients with malignant pleural mesothelioma that has grown despite treatment with
standard chemotherapy, no treatment has yet proven beneficial. The purpose of this study is
to find out what effects, both good and bad, that everolimus has on the cancer. Everolimus
works by blocking a protein that helps the cancer grow. The goal of this clinical research
study is to learn if the study drug everolimus can shrink or slow the growth of
mesothelioma. The safety of this drug will also be studied. The patients' physical state,
changes in the size of the tumor, and laboratory findings taken during the study will help
us decide if everolimus is safe and effective.

Condition Intervention Phase
Malignant Pleural Mesothelioma
Drug: everolimus
Phase 2


Study Type: Interventional

Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Official Title: Phase II Study of Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity

Additional Details:

This is a multicenter, open label, phase II study of everolimus as a second or third line
therapy for the treatment of advanced malignant pleural mesothelioma, which will also
evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who
have disease progression after one or two prior chemotherapy regimens will be eligible. In
the first stage of this design, 19 patients will be accrued. If 6 or less patients among the
first 19 patients show clinical benefit, then the study will be terminated and declared
negative. If 7 or more patients show clinical benefit, than an additional 20 patients will
be accrued to the second stage. At the end of the study, if 17 or more patients show
clinical benefit out of a total of 39 patients enrolled, the regimen will be considered
worthy of further investigation.

Enrollment Size: Both

Gender: 18 Years

Min. Age: N/A

Max. Age: No

Location and Contact Information

United States, Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States

United States, New York
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States

United States, Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania, 19104-4283, United States

Last modified: September 05, 2015.