Search
Close this search box.

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

Studies

Study First Submitted Date 2021-12-15
Study First Posted Date 2021-12-29
Last Update Posted Date 2023-01-20
Verification Month Year January 15, 2023
Verification Date 2023-01-15
Last Update Posted Date 2023-01-20

Browse Interventions

Sequence: 96054927 Sequence: 96054928 Sequence: 96054929 Sequence: 96054930
Mesh Term Pirtobrutinib Mesh Term Protein Kinase Inhibitors Mesh Term Enzyme Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term pirtobrutinib Downcase Mesh Term protein kinase inhibitors Downcase Mesh Term enzyme inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52174355 Sequence: 52174356 Sequence: 52174357 Sequence: 52174358 Sequence: 52174359
Name Leukemia, Lymphocytic, Chronic, B-Cell Name Lymphoma, Lymphocytic, Small Name Lymphoma, Mantle-Cell Name Waldenstrom Macroglobulinemia Name Ritcher's Transformation, Syndrome
Downcase Name leukemia, lymphocytic, chronic, b-cell Downcase Name lymphoma, lymphocytic, small Downcase Name lymphoma, mantle-cell Downcase Name waldenstrom macroglobulinemia Downcase Name ritcher's transformation, syndrome

Id Information

Sequence: 40160705 Sequence: 40160706
Id Source org_study_id Id Source secondary_id
Id Value 17712 Id Value J2N-OX-Y001
Id Type Other Identifier
Id Type Description Eli Lilly and Company

Countries

Sequence: 42571107 Sequence: 42571108 Sequence: 42571109 Sequence: 42571110 Sequence: 42571111 Sequence: 42571112 Sequence: 42571113 Sequence: 42571114 Sequence: 42571115
Name Australia Name Belgium Name Germany Name Ireland Name Israel Name Netherlands Name Sweden Name United Kingdom Name United States
Removed True Removed True Removed True Removed True Removed True Removed True Removed True Removed True Removed True

Interventions

Sequence: 52488401
Intervention Type Drug
Name Pirtobrutinib
Description Administered orally.

Keywords

Sequence: 79872572 Sequence: 79872573 Sequence: 79872574 Sequence: 79872575 Sequence: 79872576
Name BTKi Name BTK Inhibitor Name Bruton's tyrosine kinase inhibitor Name Hematologic Disease Name B-cell receptor
Downcase Name btki Downcase Name btk inhibitor Downcase Name bruton's tyrosine kinase inhibitor Downcase Name hematologic disease Downcase Name b-cell receptor

Browse Conditions

Sequence: 193498509 Sequence: 193498510 Sequence: 193498511 Sequence: 193498512 Sequence: 193498513 Sequence: 193498514 Sequence: 193498515 Sequence: 193498516 Sequence: 193498517 Sequence: 193498518 Sequence: 193498519 Sequence: 193498520 Sequence: 193498521 Sequence: 193498522 Sequence: 193498523 Sequence: 193498524 Sequence: 193498525 Sequence: 193498526 Sequence: 193498527 Sequence: 193498528 Sequence: 193498529 Sequence: 193498530 Sequence: 193498531 Sequence: 193498532 Sequence: 193498533
Mesh Term Lymphoma Mesh Term Waldenstrom Macroglobulinemia Mesh Term Leukemia, Lymphoid Mesh Term Leukemia, Lymphocytic, Chronic, B-Cell Mesh Term Lymphoma, Mantle-Cell Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Lymphoproliferative Disorders Mesh Term Lymphatic Diseases Mesh Term Immunoproliferative Disorders Mesh Term Immune System Diseases Mesh Term Neoplasms, Plasma Cell Mesh Term Hemostatic Disorders Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases Mesh Term Paraproteinemias Mesh Term Blood Protein Disorders Mesh Term Hematologic Diseases Mesh Term Hemorrhagic Disorders Mesh Term Leukemia Mesh Term Leukemia, B-Cell Mesh Term Chronic Disease Mesh Term Disease Attributes Mesh Term Pathologic Processes Mesh Term Lymphoma, Non-Hodgkin
Downcase Mesh Term lymphoma Downcase Mesh Term waldenstrom macroglobulinemia Downcase Mesh Term leukemia, lymphoid Downcase Mesh Term leukemia, lymphocytic, chronic, b-cell Downcase Mesh Term lymphoma, mantle-cell Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term lymphoproliferative disorders Downcase Mesh Term lymphatic diseases Downcase Mesh Term immunoproliferative disorders Downcase Mesh Term immune system diseases Downcase Mesh Term neoplasms, plasma cell Downcase Mesh Term hemostatic disorders Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term paraproteinemias Downcase Mesh Term blood protein disorders Downcase Mesh Term hematologic diseases Downcase Mesh Term hemorrhagic disorders Downcase Mesh Term leukemia Downcase Mesh Term leukemia, b-cell Downcase Mesh Term chronic disease Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes Downcase Mesh Term lymphoma, non-hodgkin
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48322018
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Loxo Oncology, Inc.

Overall Officials

Sequence: 29286854
Role Study Director
Name Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Affiliation Eli Lilly and Company

Central Contacts

Sequence: 12009683
Contact Type primary
Name In the U.S., physicians seeking help on behalf of their patients may contact Lilly at
Phone 1-800-LillyRx (1-800-545-5979)
Email Clinicaltrials.gov@lilly.com
Role Contact

Eligibilities

Sequence: 30767067
Gender All
Minimum Age 18 Years
Maximum Age N/A
Criteria 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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253922225
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years

Intervention Other Names

Sequence: 26675016 Sequence: 26675017
Intervention Id 52488401 Intervention Id 52488401
Name LY3527727 Name LOXO-305

Responsible Parties

Sequence: 28879529
Responsible Party Type Sponsor