Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS)
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|ClinicalTrials.gov Identifier: NCT03397394|
Recruitment Status : Terminated (Efficacy did not meet the continuance criteria and DMC recommended to stop enrollment.)
First Posted : January 12, 2018
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Urothelial Carcinoma Metastatic Urothelial Carcinoma Renal Pelvis Carcinoma Ureter Carcinoma Urinary Bladder Carcinoma Urethra Carcinoma Muscle Invasive Bladder Cancer||Drug: Rucaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma|
|Actual Study Start Date :||June 1, 2018|
|Actual Primary Completion Date :||December 12, 2019|
|Actual Study Completion Date :||January 15, 2020|
Oral rucaparib (monotherapy)
Rucaparib will be administered daily.
Other Name: CO-338
- Objective Response Rate (ORR) Per RECIST Version 1.1 [ Time Frame: Time from first dose to date of progression, up to approximately 19 months ]ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
- Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator [ Time Frame: Cycle 1 Day 1 to End of Treatment, up to approximately 10 months ]PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
- Overall Survival [ Time Frame: The total study time for reporting of deaths was approximately 19 months. ]Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).
- Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations [ Time Frame: From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months ]Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.
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): NCT03397394