A Phase 1 Study of the Safety and Tolerability of Intravesical Administration of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder
A nonrandomized, open-label, rising-dose, parallel-group, multi-center study of SCH 721015
in patients with papillary bladder cancer, or carcinoma in situ that is refractory to
Bacillus Calmette-Guerin. Subjects will receive a single intravesical administration of SCH
721015 with SCH 209702 in a total volume of 75 mL with a 1-hour dwell time. Subjects who at
3 months post administration demonstrate a complete response (CR on cystoscopy/biopsy and
cytology) and who did not experience dose-limiting toxicity will be allowed to receive a
second intravesical administration at the same dose level.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse events, laboratory safety tests, dose-limiting toxicity
CBC/chemistry: predose, Days 1-3, 7, 14, 21, & 28, Week 12.
United States: Food and Drug Administration