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

This study has been completed.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01659255
First received: July 6, 2012
Last updated: March 25, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Non Hodgkins Lymphoma
Chronic Lymphocytic Leukaemia
Drug: ONO/GS-4059
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic (PK) Parameter: Cmax of GS-4059 [ Time Frame: Cycle 1, Day 28 ] [ Designated as safety issue: No ]
    Cmax is defined as the maximum concentration of drug.

  • PK Parameter: AUCtau of GS-4059 [ Time Frame: Cycle 1, Day 28 ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: August 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ONO/GS-4059 Drug: ONO/GS-4059
ONO/GS-4059 capsule(s) once or twice daily (starting dose: 20 mg)

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659255

Locations
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
Sponsors and Collaborators
Gilead Sciences
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Helen Collins, MD Gilead Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01659255     History of Changes
Other Study ID Numbers: ONO-4059POE001 
Study First Received: July 6, 2012
Last Updated: March 25, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 24, 2016