A Phase I Study of SAR405838 in Patients with Advanced Cancer

Protocol
13-093
Full Title
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients with Advanced Cancer
Phase
I
Purpose

SAR405838 is an investigational anticancer drug that inhibits a protein called MDM2, which may help tumor cells survive and grow. The purpose of this study is to find the highest dose of SAR405838 that can be given safely in patients with liposarcoma and other advanced cancers that have either continued to grow despite standard therapy or for which no standard treatments exist. SAR405838 is a capsule that is taken orally (by mouth).

While this study will include patients with many types of advanced cancer, researchers are particularly interested in seeing how active SAR405838 is against liposarcoma, a type of cancer that has very high levels of MDM2. Because of this, more spots in the study are reserved for patients with liposarcoma than for other types of cancer.

Eligibility

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

  • Patients must have liposarcoma or an advanced solid tumor that has continued to grow despite standard therapy or for which no standard therapies exist. For patients with cancers other than liposarcoma, the tumor must not contain mutations in the p53 gene.
  • At least 2 weeks must have passed since completion of prior therapies and entry into the study.
  • 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.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mark A. Dickson at 646-888-4164.

Disease(s)
Sarcomas: Soft Tissue Sarcoma
Solid Tumors
Locations
Related Diseases