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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Relapsed/Refractory B-cell Malignancies

Treatments: Drug: Tirabrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02457559

GS-US-401-1787

2015-001404-58 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to determine the long-term safety and tolerability of tirabrutinib in adults with relapsed/refractory B-cell malignancy who have tolerated and achieved stable disease or improved with tirabrutinib treatment while enrolled in a prior (parent study) tirabrutinib study (NCT01659255). The dosing regimen will be based on the prior dosing regimen from the parent study.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 12 patient groups

Tirabrutinib 40 mg once daily (CLL)

Experimental group

Description:

Participants with relapsed/refractory chronic lymphocytic leukemia (CLL) received tirabrutinib 40 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 80 mg once daily (CLL)

Experimental group

Description:

Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 160 mg once daily (CLL)

Experimental group

Description:

Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 320 mg once daily (CLL)

Experimental group

Description:

Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 400 mg once daily (CLL)

Experimental group

Description:

Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 500 mg once daily (CLL)

Experimental group

Description:

Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 600 mg once daily (CLL)

Experimental group

Description:

Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 300 mg twice daily (CLL)

Experimental group

Description:

Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 160 mg once daily (NHL)

Experimental group

Description:

Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 320 mg once daily (NHL)

Experimental group

Description:

Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 480 mg once daily (NHL)

Experimental group

Description:

Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib

Tirabrutinib 600 mg once daily (NHL)

Experimental group

Description:

Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.

Treatment:

Drug: Tirabrutinib