A Phase 1B/II Study of GDC-0449 Plus RO4929097 in Advanced/Metastatic Sarcomas

Protocol
10-049
Full Title
A Phase IB/II Study of GDC-0449 (NSC 747691) in Combination with R04929097 a Gamma-Secretase Inhibitor (GSI) in Advanced/Metastatic Sarcomas (NCI #8406)
Phase
I/II
Purpose

GDC-0449 and RO4929097 are two new investigational drugs currently being assessed for the treatment of sarcoma. The purpose of the phase IB portion of this study is to find the optimal doses of these drugs to use in patients with metastatic and recurrent sarcoma. The purpose of the phase II portion is to see how effective the drugs are against sarcoma. Both drugs are pills that are taken orally (by mouth).

Hedgehog” and “Notch” are two groups of proteins that cause cancer cells to grow continuously. GDC-0449 blocks the activity of the Hedgehog pathway, while RO4929097 blocks the activity of the Notch pathway. Laboratory studies have shown that a Hedgehog inhibitor and a Notch inhibitor are more effective when they are used together than separately.

Eligibility

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

  • Patients must have sarcoma that has recurred or metastasized despite prior chemotherapy.
  • Patients may not have had more than four prior regimens of chemotherapy.
  • At least 2 weeks must have passed since completion of prior chemotherapy and entry into the study (4 weeks for bevacizumab and immunotherapies).
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Mrinal Gounder at 646-888-4226.

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