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NCT05172700 Clinical Trial

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

Waldenstrom Macroglobulinemia Clinical Trial

Official title:
Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05172700
Other study ID # 17712
Secondary ID J2N-OX-Y001
Status Available
Phase
First received
Last updated

Study information
Verified date October 15, 2023
Source Eli Lilly and Company
Contact In the U.S., physicians seeking help on behalf of their patients
Phone 1-800-LillyRx (1-800-545-5979)
Email Clinicaltrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pirtobrutinib
Administered orally.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Loxo Oncology, Inc.
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