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Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT05172700
Collaborator
(none)
62
Locations

Study Details

Study Description

Brief Summary

This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Have been diagnosed with:

    • CLL or SLL and have received treatment with the following five classes of therapy: Chemotherapy, anti-cluster of differentiation (anti-cd) 20 antibody, covalent Bruton's tyrosine kinase (BTK) inhibitor, B-cell lymphoma-2 (BCL-2) inhibitor, and phosphatidylinositol 3-kinase (PI3K) inhibitor

    • MCL that has been previously treated with a covalent BTK inhibitor

    • Richter's Transformation (RT) with previous Richter's directed-therapy

    • Waldenstrom macroglobulinemia (WM), previously treated with chemotherapy, anti-CD20 antibody and a covalent BTK inhibitor

    • Are not eligible for an ongoing pirtobrutinib clinical trial

    Exclusion Criteria:

    • Inadequate organ function

    • Significant cardiovascular disease

    • History of allogenic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified Tcell (CAR-T) therapy within 60 days

    • Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitis B or C virus or cytomegalovirus (CMV) infection

    • Active, uncontrolled autoimmune cytopenia

    • Clinically significant active malabsorption syndrome

    • Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Hospital Stanford California United States 94305-5208
    2 Rocky Mountain Cancer Center Boulder Colorado United States 80303
    3 Memorial Healthcare System Pembroke Pines Florida United States 33316
    4 Florida Cancer Specialists Trinity Florida United States 34655
    5 University of Chicago Hospital Chicago Illinois United States 60637
    6 Universtiy of Kansas Cancer Center Overland Park Kansas United States 66210
    7 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    8 University of Minnesota Hospital Minneapolis Minnesota United States 55455
    9 Washington University School of Medicine Saint Louis Missouri United States 63110
    10 Logan Health Research Kalispell Montana United States 59901
    11 Community Medical Center Missoula Montana United States 59804
    12 Medical Diagnostic Associates at Carol G. Simon Cancer Center Overlook Medical Center Summit New Jersey United States 07901
    13 Northwell Health/CLL Research and Treatment Program New Hyde Park New York United States 11563
    14 Memorial Sloan Kettering New York New York United States 10021
    15 University of Rochester Rochester New York United States 14642
    16 Novant Health Cancer Institute Charlotte North Carolina United States 28204
    17 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    18 Willamette Valley Cancer Institute Eugene Oregon United States 97401
    19 UPMC Hillman Cancer Center Pittsburgh Pennsylvania United States 15232-1305
    20 MD Anderson Cancer Center, IPS Houston Texas United States 77030
    21 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    22 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    23 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    24 PeaceHealth St Joseph Cancer Ctr Bellingham Washington United States 98225
    25 Swedish Cancer Institute; STE 1020 Seattle Washington United States 98104
    26 Virginia Mason Medical Center Seattle Washington United States 98111
    27 Kaiser Permanente WA Capitol Hill Seattle Washington United States 98112
    28 American Oncology Network Spokane Washington United States 99208
    29 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53590
    30 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53705-2275
    31 UW Carbone Cancer Center Madison Wisconsin United States 53715
    32 Western Cancer Centre Dubbo New South Wales Australia 2830
    33 Liverpool Hospital Liverpool New South Wales Australia 2170
    34 Sir Charles Gairdner Hospital Perth Western Australia Australia 6003
    35 UZ Leuven Leuven Vlaams-Brabant Belgium 3000
    36 UZ Leuven Leuven Vlaams-Brabant Belgium 3000
    37 AZ St Jan Brugge Oostende AV Brugge Belgium 8000
    38 Universitätsmedizin Göttingen Göttingen Niedersachsen Germany 37075
    39 University Hospital Cologne Cologne NRW Germany 50937
    40 Second Medical Department, University Hospital Schleswig-Holstein Kiel Schleswig-Holstein Germany 25259
    41 Charité-Campus Benjamin Franklin-Hematology and Oncology Berlin Germany 12203
    42 Universitätsklinikum Schleswig-Hol Kiel Germany 24105
    43 University Hospital Galway Galway Ireland H91 YR71
    44 Bnai Zion Medical Center Haifa Israel 3339419
    45 Beilinson Hospital Petah Tikva Israel
    46 Rijnstate Arnhem Arnhem Gelderland Netherlands 6815 AD
    47 Karolinska University Hospital, ME Hematologi Stockholm Sweden SE-17176
    48 University Hospital Crosshouse Crosshouse Ayrshire United Kingdom KA2QBE
    49 Royal Cornwall Hospital Truro Cornwall United Kingdom TR1 3LJ
    50 Cumberland Infirmary Carlisle Cumbria United Kingdom CA2 7HY
    51 Derriford Hospital Plymouth Devon United Kingdom PL6 8DH
    52 Eastbourne District General Hospiatl Eastbourne E.susx United Kingdom BN21 2UD
    53 St Bartholomew's Hospital London London, City Of United Kingdom EC1A 7BE
    54 University College London Hospital London London, City Of United Kingdom NW1 2PG
    55 Arrowe Park Hospital Wirral Merseyside United Kingdom L49 5LN
    56 Nottingham City Hospital Nottingham Nottinghamshire United Kingdom NG5 1PB
    57 Dumfries & Galloway Royal Infirmary Dumfries Scotland United Kingdom DG2 8RX
    58 NCCC, Freeman Hospital Newcastle upon Tyne Tyne And Wear United Kingdom NE7 7DN
    59 Royal United Hospital Bath United Kingdom BA1 3NG
    60 University College London Hospitals NHS Foundation Trust London United Kingdom NW1 2BU L
    61 University College London Hospital London United Kingdom NW1 2PG
    62 Royal Marsden Hospital London United Kingdom SW3 6JJ

    Sponsors and Collaborators

    • Loxo Oncology, Inc.

    Investigators

    • Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Loxo Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT05172700
    Other Study ID Numbers:
    • 17712
    • J2N-OX-Y001
    First Posted:
    Dec 29, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 15, 2022
    Keywords provided by Loxo Oncology, Inc.
    BTKi
    BTK Inhibitor
    Bruton's tyrosine kinase inhibitor
    Hematologic Disease
    B-cell receptor
    Additional relevant MeSH terms:
    Lymphoma
    Waldenstrom Macroglobulinemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Lymphoma, Mantle-Cell

    Study Results

    No Results Posted as of Aug 18, 2022