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Phase I Study of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory NHL and CLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01659255
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : March 28, 2016
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This is an open-label, multi-center, phase I dose-escalation study to investigate the safety and tolerability of ONO/GS-4059 given as monotherapy to patients with relapsed/refractory NHL and CLL.

Condition or disease Intervention/treatment Phase
Non Hodgkins Lymphoma Chronic Lymphocytic Leukaemia Drug: ONO/GS-4059 Phase 1

Detailed Description:
An open-label, multi-center, non-randomized phase I dose-escalation study to investigate the safety and tolerability of ONO/GS-4059 given as monotherapy in patients with relapsed/refractory Non-Hodgkin's lymphoma (NHL) and relapsed/refractory chronic lymphocytic leukemia (CLL). Non-Hodgkin's lymphoma are a heterogeneous group of malignancies which have a varied clinical and biological features. Leukemia is a type of cancer of the blood or bone marrow characterized by an abnormal increase of immature white blood cells. Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia affecting the blood and bone marrow.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : August 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ONO/GS-4059 Drug: ONO/GS-4059
ONO/GS-4059 capsule(s) once or twice daily (starting dose: 20 mg)

Primary Outcome Measures :
  1. Overall safety profile of ONO/GS-4059, including incidence of dose-limiting toxicities, adverse events (AEs), and clinically significant electrocardiogram (ECG) and laboratory abnormalities. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter: Cmax of GS-4059 [ Time Frame: Cycle 1, Day 28 ]
    Cmax is defined as the maximum concentration of drug.

  2. PK Parameter: AUCtau of GS-4059 [ Time Frame: Cycle 1, Day 28 ]
    AUCtau is defined as concentration of drug over time.

  3. Overall Response Rate [ Time Frame: Cycles 3 and 6, 9, 12, 18, 24, 30, 36 (28 days for each cycle). ]
    Overall response rate will be assessed as defined by guidelines on NHL and CLL, accounting for duration of response, complete response rate, progression-free survival, and overall survival.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01659255

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CHRU - Hopital Claude HURIEZ
Lille, France, 59037
Centre hospitalier Lyon Sud
Lyon, France, 69495
CHU St Eloi
Montpellier, France, 34295
United Kingdom
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Gilead Sciences
Ono Pharmaceutical Co. Ltd
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Study Director: Helen Collins, MD Gilead Sciences
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gilead Sciences Identifier: NCT01659255    
Other Study ID Numbers: ONO-4059POE001
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell