Skip to main content
OpenTrials
Completed

NCT Number: NCT01659255

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non Hodgkins Lymphoma Chronic Lymphocytic Leukaemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHRU - Hopital Claude HURIEZ, Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Key Exclusion Criteria:

  • Central nervous system (CNS) lymphoma.
  • Women who are pregnant or lactating.

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

Treatment and study plan

Tirabrutinib

Drug

Capsules administered orally

Other names: ONO/GS-4059

Primary outcomes

  1. Percentage of Participants Experiencing Dose-Limiting Toxicities

    Time frame: Day 1 through Day 28

    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.

Secondary outcomes

  1. Overall Response Rate

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

    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

  2. Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib

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

    Cmax is defined as the maximum concentration of drug.

  3. PK Parameter: AUCtau of Tirabrutinib

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

    AUCtau is defined as concentration of drug over dosing interval.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

An Open-label, Multi-Center, Non-Randomised Phase I Dose-Escalation Study to Investigate the Safety and Tolerability of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL) and Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Aug 7, 2012
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.