Clinical Trials

A Phase Ib Study of Combination Therapy with MSC1936369B and SAR245409 in Patients with Locally Advanced or Metastatic Solid Tumors

Protocol
12-107
Full Title
An Open-Label, Phase Ib Dose Escalation Trial of Oral Combination Therapy with MSC1936369B and SAR245409 in Subjects with Locally Advanced or Metastatic Solid Tumors
Purpose

The purpose of this study is to find the best doses of the two investigational drugs MSC1936369B and SAR245409 when they are given together in patients with locally advanced or metastatic solid tumors that persist despite standard therapy or for which no standard therapy exists. Both drugs are taken orally (by mouth).

MSC1936369B works by inhibiting a protein called MEK that fuels cancer growth in some patients. SAR245409 blocks PI3K and mTOR, two other proteins that drive the growth of some cancers.

Investigator
Naiyer A. Rizvi, MD
Naiyer A. Rizvi - Physician Profile
Co-Investigators
Gary K. Schwartz, MD -- Chief, Melanoma and Sarcoma Service
Gary K. Schwartz - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a locally advanced or metastatic solid tumor that persists despite standard therapy or for which no standard therapy exists.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients may not have previously received a MEK or PI3K inhibitor.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Naiyer Rizvi at 646-888-4204.

Locations
ClinicalTrials.gov