Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies

• Status: Completed
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the long-term safety, tolerability, and efficacy of tirabrutinib in adults in a prior tirabrutinib study and whose disease had not progressed on the parent study. The dosing regimen will be based on the prior dosing regimen from the parent study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• Currently enrolled in a prior tirabrutinib study

• Did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment in this study

• Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the baseline of the prior study prior to Day 1 of this study

• Negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal)

• Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol.

• Lactating females must agree to discontinue nursing before the study drug is administered

• Ability and agreement to attend protocol-specified visits at the study site

• Able to comprehend and willing to sign the informed consent form

Key Exclusion Criteria:

• Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.