Phase I Study of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory NHL and CLL
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ClinicalTrials.gov Identifier: NCT01659255 |
Recruitment Status :
Completed
First Posted : August 7, 2012
Last Update Posted : March 28, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Hodgkins Lymphoma Chronic Lymphocytic Leukaemia | Drug: ONO/GS-4059 | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: ONO/GS-4059 |
Drug: ONO/GS-4059
ONO/GS-4059 capsule(s) once or twice daily (starting dose: 20 mg) |
- 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 ]
- Pharmacokinetic (PK) Parameter: Cmax of GS-4059 [ Time Frame: Cycle 1, Day 28 ]Cmax is defined as the maximum concentration of drug.
- PK Parameter: AUCtau of GS-4059 [ Time Frame: Cycle 1, Day 28 ]AUCtau is defined as concentration of drug over time.
- 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.

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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:
- 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.
Exclusion Criteria:
- Central nervous system (CNS) lymphoma.
- Women who are pregnant or lactating.

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 ClinicalTrials.gov identifier (NCT number): NCT01659255
France | |
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 |
Study Director: | Helen Collins, MD | Gilead Sciences |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov 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 |
Lymphoma Leukemia Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell |