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Purpose

Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Are currently enrolled and active in the originator study, LOXO-BTK-18001. A participant is considered active in the study if they are: - receiving study intervention - in the short-term follow-up period, or - in the long-term follow-up period

Exclusion Criteria

  • Were a participant in the Phase 1b cohort of Study LOXO-BTK-18001

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
JZ01 Pirtobrutinib 		Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.
  • Drug: Pirtobrutinib
    Administered orally.
    Other names:
    • LOXO-305
    • LY3527727

Recruiting Locations

Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136-1002
Contact:
954-265-6549

Florida Cancer Specialists
Sarasota 4172131, Florida 4155751 34232-6422
Contact:
941-377-9993

The Emory Clinic
Atlanta 4180439, Georgia 4197000 30322-1013
Contact:
404-778-3708

Northwestern University
Chicago 4887398, Illinois 4896861 60611-3013
Contact:
312-908-5250

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02115
Contact:
617-632-5847

Mayo Clinic- Minnesota
Rochester 5043473, Minnesota 5037779 55905
Contact:
507-284-2511

University Of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 69198
Contact:
402-559-5166

Cayuga Cancer Center
Ithaca 5122432, New York 5128638 14850
Contact:
607-272-5414

Northwell Health
Lake Success 5123853, New York 5128638 11042-1118
Contact:
516-734-8959

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York 5128581, New York 5128638 10065-6007
Contact:
646-608-4273

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York 5128581, New York 5128638 10065-6007

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710-4000
Contact:
919-684-8111

Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210-1063
Contact:
614-293-3196

University of Pennsylvania Hospital
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
215-662-3933

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203-2659
Contact:
615-524-4074

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030-4000
Contact:
713-792-2860

Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104-3588
Contact:
908-208-4685

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226-3548
Contact:
414-805-4600

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.