A Phase II Study of Pimasertib with SAR245409 or a Placebo in Women with Previously Treated Inoperable Low-Grade Ovarian Cancer

Protocol
13-173
Full Title
Phase II Randomized Double Blind Placebo Controlled Trial of Combination of Pimasertib with SAR245409 or of Pimasertib with SAR245409 Placebo in Subjects with Previously Treated Unresectable Low Grade Ovarian Cancer
Phase
II
Purpose

The purpose of this study is to evaluate the safety and effectiveness of the investigational drugs pimasertib and SAR245409 in women with previously treated inoperable low-grade ovarian or primary peritoneal cancer. Patients will be randomly assigned to receive pimasertib with SAR245409 or pimasertib with a placebo. Researchers will also search for genetic markers that may predict how a patient will respond to treatment.

Pimasertib works by inhibiting MEK, a protein which fuels the growth of some cancers. SAR245409 works by inhibiting PI3 kinase and mTOR, which are also proteins involved in cancer growth. Doctors think that both drugs given together may be more effective than either alone. Both pimasertib and SAR245409 are taken orally (by mouth).

Eligibility

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

  • Patients must have low-grade ovarian or primary peritoneal cancer that cannot be cured with surgery.
  • Patients should have received at least one prior regimen of systemic therapy (chemotherapy) for their cancer.
  • At least 4 weeks must have passed since completion of previous treatment and entry into the study. Patients may not have received inhibitors of MEK, PI3 kinase, or mTOR.
  • 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. Rachel Grisham at 646-888-4653.

Disease(s)
Ovarian Cancer
Locations
Related Diseases

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