The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Rucaparib will be administered daily.
Objective Response Rate (ORR) Per RECIST Version 1.1
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.
Time frame: Time from first dose to date of progression, up to approximately 19 months
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
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.
Time frame: Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
Overall Survival
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).
Time frame: The total study time for reporting of deaths was approximately 19 months.
Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pinnacle Oncology, Honor Health
Scottsdale, Arizona, United States
University of California San Diego (UCSD), Moores Cancer Center
La Jolla, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Universityof California, Irvine
Orange, California, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, United States
Stanford University School of Medicine
Stanford, California, United States
Hartford Health Care Cancer Institute
Hartford, Connecticut, United States
Eastern Connecticut Hematology & Oncology Associates (ECHO)
Norwich, Connecticut, United States
Medstar Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida, United States
...and 54 more locations
Time frame: From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months