A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib
Sponsor: Eli Lilly and Company
ClinicalTrials ID:NCT06876649
The master protocol J2N-MC-JZNY assesses the long-term safety and efficacy of pirtobrutinib for participants from completed Lilly-sponsored studies. Eligible participants can continue treatment or follow-up visits. Pirtobrutinib is administered orally as part of the intervention.
Patient Parameters
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Program Overview
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.
Eligibility Criteria
Inclusion Criteria
- Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.
Exclusion Criteria
- Are pregnant, or intend to become pregnant during the study, or within 30 days of last dose of study treatment or to breastfeed during the study or within 1 week of the last dose of study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California Medical Center | 94143-2204 | San Francisco | California |
| Sylvester Comprehensive Cancer Center | 33136-1002 | Miami | Florida |
| Florida Cancer Specialists | 34232-6422 | Sarasota | Florida |
| The Emory Clinic | 30322-1013 | Atlanta | Georgia |
| Northwestern University | 60611-3013 | Chicago | Illinois |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Mayo Clinic- Minnesota | 55905 | Rochester | Minnesota |
| University Of Nebraska Medical Center | 69198 | Omaha | Nebraska |
| Northwell Health | 11042-1118 | Lake Success | New York |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | 10065-6007 | New York | New York |
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