A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).
UCLA Medicine Hematology and Oncology
Los Angeles, California, United States
Best Overall Response Rate by Investigator
Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
Time frame: From first dose of study drug until disease progression (up to approximately 2 years)
Overall Response Rate by Independent Radiology Review
Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
Time frame: From first dose of study drug until disease progression (up to approximately 2 years)
Duration of Response
Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.
Time frame: From first dose of study drug until disease progression (up to approximately 2 years)
Disease Control Rate
Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.
Time frame: From first dose of study drug until disease progression (up to approximately 2 years)
Progression-free Survival
Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.
Time frame: From first dose of study drug until disease progression (up to approximately 2 years)
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Beth Israel Deaconess Medical Cancer Surgical Pavilion
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States
...and 9 more locations
Overall Survival
Measure of clinical benefit, defined as the duration from study enrollment to death.
Time frame: From first dose of study drug until disease progression (up to approximately 2 years)
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: From first dose of study drug until disease progression (up to approximately 2 years)
Steady State Minimum Concentration [Cmin]
Rucaparib pharmacokinetics
Time frame: From first dose of study drug until disease progression (up to approximately 2 years)