Phase 2 study of RO4929097, a gamma-secretase inhibitor, in metastatic melanoma: SWOG 0933.

ABSTRACT:

Background

Aberrant Notch activation confers a proliferative advantage to many human tumors, including melanoma. This phase 2 trial assessed the antitumor activity of RO4929097, a gamma-secretase inhibitor of Notch signaling, with respect to the progression-free and overall survival of patients with advanced melanoma.

Methods

Chemotherapy-naive patients with metastatic melanoma of cutaneous or unknown origin were treated orally with RO4929097 at a dose of 20 mg daily 3 consecutive days per week. A 2-step accrual design was used with an interim analysis of the first 32 patients and with continuation of enrollment if 4 or more of the 32 patients responded.

Results

Thirty-six patients from 23 institutions were enrolled; 32 patients were evaluable. RO4929097 was well tole

SUBMITTER: Lee SM 

PROVIDER: S-EPMC4304973 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature