A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: September 28, 2007
Last Update Posted: March 27, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The purpose of this first-in-human study is to determine the safety and tolerability of SCH 721015 in subjects with transitional cell carcinoma of the bladder.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of the Safety and Tolerability of Intravesical Administration of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Adverse events, laboratory safety tests, dose-limiting toxicity [ Time Frame: CBC/chemistry: predose, Days 1-3, 7, 14, 21, & 28, Week 12. ]
- Adverse events, laboratory safety tests, dose-limiting toxicity [ Time Frame: Additional hematology on Days 4, 5, & 6. ]
- Adverse events, laboratory safety tests, dose-limiting toxicity [ Time Frame: AEs: Duration of study; up to 3 years postdose for serious events. ]
- Adverse events, laboratory safety tests, dose-limiting toxicity [ Time Frame: ECG and VS - predose and selected postdose time points. ]
Secondary Outcome Measures:
- Timed urine collections for IFNα2b excretion & IP-10. [ Time Frame: Days 1-7, 10, 14, 21, & 28/29. ]
- Urine samples for SCH 721015 DNA content. [ Time Frame: Predose, Days 1-7 & 14. ]
- Blood samples for SCH 721015 DNA; SCH 209702, & IFNα2b levels; antiadenoviral & anti-IFNα2b antibodies [ Time Frame: Pre- & postdose for SCH 721015 DNA; SCH 721015, & IFNα2b levels; & postdose for antibodies. ]
- Urine cytology & FISH [ Time Frame: Days 1, 30 & 90 ]
- Cystoscopy & bladder biopsies [ Time Frame: Screening & Day 90 ]
|Study Start Date:||September 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
|Experimental: SCH 721015 with SCH 209702||
Genetic: SCH 721015 with SCH 209702
Each subject receives a single intravesical administration of SCH 721015 with SCH 209702 at dose levels of 1 x 10^9 to 3 x 10^11 particles/mL (based on assessment of tolerability, intermediate dose levels may be used).
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.
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