The Food-Effect Bioavailability Study of Ro 31-7453, a Novel Cell Cycle Inhibitor, in Stable Patient Volunteers With Solid Tumors
OBJECTIVES: I. Assess the impact of food on the bioavailability of Ro 31-7453 in patients
with locally advanced or metastatic solid tumors.
OUTLINE: This is a randomized, crossover study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive oral Ro 31-7453 under fasting conditions on day 1.
After a 1-week washout period, patients receive oral Ro 31-7453 under fed conditions. Arm
II: Patients receive fed treatment as in arm I on day 1. After a 1-week washout period,
patients receive fasted treatment as in arm I. Both arms: At the start of week 3, patients
may continue to receive oral Ro 31-7453 every 12 hours on days 1-4. Treatment repeats every
3 weeks for at least 24 weeks in the absence of disease progression or unacceptable
toxicity. Patients are followed at 7 days.
PROJECTED ACCRUAL: A total of 10 patients (5 per arm) will be accrued for this study.
Primary Purpose: Treatment
Steven Soignet, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|