BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02657486|
Recruitment Status : Active, not recruiting
First Posted : January 15, 2016
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Non-Muscle-Invasive Urothelial Carcinoma||Drug: BGJ398||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
BGJ398 will be administered at a dose of 125 mg orally once daily on a three weeks on, one week off schedule.
- tumor response [ Time Frame: week 7 ]with cystoscopy and cytology. A complete response will be defined as complete disappearance of the marker lesion at the week 7 evaluation, as determined by a negative cystoscopy and cytology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657486
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Jonathan Rosenberg, MD||Memorial Sloan Kettering Cancer Center|