Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations
|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: NCT03448718|
Recruitment Status : Active, not recruiting
First Posted : February 28, 2018
Last Update Posted : August 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Urothelial Cancer||Drug: Olaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations|
|Actual Study Start Date :||April 17, 2018|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2023|
Experimental: Olaparib Monotherapy
The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of > 30 to < 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of > 30 to < 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Other Name: Lynparza
- Objective Response Rate [ Time Frame: 36 Months ]Estimate the objective response rate (per RECIST 1.1 or MD Anderson Criteria for bone-only metastatic disease) to treatment with olaparib in subjects with metastatic urothelial cancer harboring somatic DDR alterations. Objective response rate will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1.
- Progression-Free Survival [ Time Frame: 36 Months ]Progression-free survival is defined as the time from Day 1 of treatment until the criteria for disease progression is met as defined by RECIST 1.1 or death as a result of any cause.
- Overall Survival [ Time Frame: 36 Months ]Overall survival is defined as the time from Day 1 of treatment until death as a result of any cause.
- Adverse Event Assessment [ Time Frame: 36 Months ]Assess all grade 3 and 4 adverse events as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
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): NCT03448718
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|Karmanos Cancer Center (Wyane State University)|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029-6542|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Tennessee|
|Vanderbilt-Ingran Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Utah|
|Huntsman Cancer Institute University of Utah|
|Salt Lake City, Utah, United States, 84112-5550|
|Principal Investigator:||Matthew Galsky, MD||Mt Sinai School of Medicine|