Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors
- Determine the maximum tolerated dose of R115777 in patients with advanced malignant
- Assess the toxicity of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug in these patients.
- Determine the potential predictors of response in patients treated with drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days
in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A minimum of 20 patients will be accrued for this study within 12 months.
Primary Purpose: Treatment
Primo N. Lara, MD
University of California, Davis
United States: Federal Government
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|University of California Davis Cancer Center||Sacramento, California 95817|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|City of Hope Medical Group||Pasadena, California 91105|