Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL

Gilead Sciences90 enrolled

Overview

The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Hodgkins Lymphoma Chronic Lymphocytic Leukaemia

Interventions

TirabrutinibDRUG

Capsules administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Males or females with a confirmed diagnosis of and documented history of relapsed or refractory malignant disease (B-cell lymphoma and/or CLL) for which no therapy of curative or high priority exists and for whom treatment with a Btk inhibitor may be deemed appropriate. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Key Exclusion Criteria: 1. Central nervous system (CNS) lymphoma. 2. Women who are pregnant or lactating. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (6)

CHRU - Hopital Claude HURIEZ

Lille, France

Centre hospitalier Lyon Sud

Lyon, France

CHU St Eloi

Montpellier, France

University Hospital of Wales

Cardiff, United Kingdom

Outcomes

Primary Outcomes

Percentage of Participants Experiencing Dose-Limiting Toxicities

Dose Limiting Toxicities (DLT) were defined as follows: * All Common Terminology Criteria (CTC) Grade 4 tirabrutinib related adverse events * All CTC Grade 3 tirabrutinib related adverse events, with the exception of the following: * CTC Grade 3 lymphocytosis considered an expected outcome of therapy Any toxicity which in the opinion of the Investigator is attributed to a participant's underlying disease was not considered a DLT.

Time frame: Day 1 through Day 28

Secondary Outcomes

Overall Response Rate

Overall response rate (ORR) was defined as the percentage of participants who achieve a best overall response of complete remission (CR, unconfirmed complete response (CRu), complete response with incomplete marrow recovery (CRi)) or partial remission (PR, nodal PR) during study as assessed by the investigator. ORR assessment was defined per following standardized criteria: * NHL: Cheson, 1999 * CLL: International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008

Time frame: Up to Cycle 37 (28 days for each cycle) plus 6-month intervals thereafter until disease progression (maximum: up to 39 months)

Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib

Cmax is defined as the maximum concentration of drug.

Time frame: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28

PK Parameter: AUCtau of Tirabrutinib

AUCtau is defined as concentration of drug over dosing interval.

Time frame: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28

Data from ClinicalTrials.gov

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