A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)

Lilly

Status and phase: Completed; Phase 2

Conditions: Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid

Treatments: Drug: LOXO-305

Study type: Interventional

Funder types: Industry

Identifiers

NCT04849416

17746

J2N-MC-JZNJ (Other Identifier)

Details and patient eligibility

About

A study of the safety, side effects, and effectiveness of LOXO-305 in Chinese adults with lymphoma or chronic leukemia who have already had standard of care treatment. Participation could last up to four years.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Participants with histologically confirmed B-cell malignancy including:

  • Mantle cell lymphoma (MCL) treated with a prior Bruton's tyrosine kinase (BTK) inhibitor containing regimen;
  • CLL/SLL treated with a prior BTK inhibitor containing regimen;
  • Other types of B-cell NHL

• All participants must have disease requiring treatment, for CLL/SLL participants, at least 1 indication for treatment consistent with IWCLL 2018 criteria is required

• Eastern Cooperative Oncology Group 0-2

• Adequate hematologic status, coagulation, hepatic and renal function

Exclusion Criteria

• Lack of adequate wash-out period for investigational agent or anticancer therapy, major surgery, and radiotherapy prior to the first dose of study treatment
• Participants requiring therapeutic anticoagulation with warfarin
• Known central nervous system (CNS) involvement by systemic lymphoma. Primary CNS lymphoma is excluded
• Significant cardiovascular disease
• Prolongation of the QT interval
• Test positive for human immunodeficiency virus (HIV)
• Current treatment with certain strong cytochrome P450 3A4 (CYP450 3A4) inhibitors or inducers and/or strong p-glycoprotein (P-gp) inhibitors
• Pregnancy or lactation
• Active second malignancy
• Prior treatment with LOXO-305
• Known hypersensitivity to any component or excipient of LOXO-305

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

LOXO-305

Experimental group

Description:

Participants received 200 mg of LOXO-305 administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.

Treatment:

Drug: LOXO-305