A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of SU011248 in the Treatment of Patients With Imatinib Mesylate (Gleevec™, Glivec®)-Resistant or Intolerant Malignant Gastrointestinal Stromal Tumor
- Compare the time to tumor progression in patients with imatinib mesylate-resistant or
-intolerant malignant gastrointestinal stromal tumor treated with SU011248 vs placebo.
- Compare other measures of antitumor efficacy of these regimens in these patients.
- Compare pain control, analgesic usage, tumor-related signs and symptoms, health status,
and performance status in patients treated with these regimens.
- Determine the safety and tolerability of SU011248 in these patients.
- Correlate plasma concentration of this drug with efficacy and safety parameters in
- Correlate potential biomarkers with clinical outcomes in patients treated with these
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior imatinib mesylate response or intolerance (progressive
disease within 6 months of the start of therapy vs progressive disease beyond 6 months from
the start of therapy vs intolerance) and baseline MPQ score based on the median value of the
worst daily pain over a 7-day period before randomization (0 vs ≥ 1). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral SU011248 once daily on days 1-28.
- Arm II: Patients receive oral placebo once daily on days 1-28. In both arms, courses
repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients in arm II with disease progression who meet all eligibility criteria for further
treatment may crossover to arm I to receive open-label treatment with SU011248.
Quality of life is assessed on days 1 and 28 of each course and at the end of study
Patients are followed at 30 days and then every 2 months for up to 3 years.
PROJECTED ACCRUAL: A total of 357 patients (238 in arm I and 119 in arm II) will be accrued
for this study within 18 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Robert Maki, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|