A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT06876649
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pirtobrutinib — DRUG
    Administered orally.

Study Details

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.

Key Dates

Start date
May 20, 2025
Status verified
Feb 2026
Primary completion
May 31, 2030
Completion
Dec 31, 2032

Study Design

Enrollment
787 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JZ01 Pirtobrutinib
    Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.

Primary Outcome Measure

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 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (20)

FacilityCityStateZIPSite coordinators
Cancer Specialists, LLCJacksonvilleFlorida32256
Ayed Ayed (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-1002
954-265-6549
Alvaro Alencar (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsSarasotaFlorida34232-6422
941-377-9993
Manish Patel (PRINCIPAL_INVESTIGATOR)
The Emory ClinicAtlantaGeorgia30322-1013
404-778-3708
Jonathon Cohen (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611-3013
60611-3013
Shuo Ma (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
617-632-5847
Jennifer Brown (PRINCIPAL_INVESTIGATOR)
Mayo Clinic- MinnesotaRochesterMinnesota55905
507-284-2511
Yucai Wang (PRINCIPAL_INVESTIGATOR)
University Of Nebraska Medical CenterOmahaNebraska69198
402-559-5166
Matthew Lunning (PRINCIPAL_INVESTIGATOR)
Cayuga Cancer CenterIthacaNew York14850
607-272-5414
Cynthia Davis (PRINCIPAL_INVESTIGATOR)
Northwell HealthLake SuccessNew York11042-1118
516-734-8959
Steven Allen (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer Center (MSKCC) - New YorkNew YorkNew York10065-6007
646-608-4273
Prioty Islam (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer Center (MSKCC) - New YorkNew YorkNew York10065-6007
646-608-4273
Prioty Islam (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer Center (MSKCC) - New YorkNew YorkNew York10065-6007
Prioty Islam (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710-4000
919-684-8111
Matthew McKinney (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-1063
614-293-3196
Jennifer Woyach (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104
215-662-3933
Sunita Nasta (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203-2659
615-524-4074
Michael Byrne (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
713-792-2860
Michael Wang (PRINCIPAL_INVESTIGATOR)
Swedish Cancer InstituteSeattleWashington98104-3588
98104-3588
Swathi Namburi (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226-3548
414-805-4600
Nirav Shah (PRINCIPAL_INVESTIGATOR)

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