A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib
Summary
The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.
Arms & interventions
- DrugPirtobrutinib
Administered orally.
Outcome measures
Primary
Percentage of Participants with a Grade ≥3 treatment-emergent AEs
Time frame: Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier
Secondary
Overall Survival
Time frame: Time from randomization in a randomized Originator study, or from the first dose in a non-randomized Originator study, until death from any cause (Up to 93 Months)
Eligibility criteria
Study locations (20)
Cancer Specialists, LLC
Jacksonville, Florida, 32256
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136-1002
Florida Cancer Specialists
Sarasota, Florida, 34232-6422
The Emory Clinic
Atlanta, Georgia, 30322-1013
Northwestern University
Chicago, Illinois, 60611-3013
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Mayo Clinic- Minnesota
Rochester, Minnesota, 55905
University Of Nebraska Medical Center
Omaha, Nebraska, 69198
Cayuga Cancer Center
Ithaca, New York, 14850
Northwell Health
Lake Success, New York, 11042-1118
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007
Duke University Medical Center
Durham, North Carolina, 27710-4000
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1063
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Tennessee Oncology
Nashville, Tennessee, 37203-2659
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Swedish Cancer Institute
Seattle, Washington, 98104-3588
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3548