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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd Identifier:
First received: July 6, 2012
Last updated: August 17, 2015
Last verified: August 2015
This is an open-label, multi-centre, phase I dose-escalation study to investigate the safety and tolerability of ONO-4059 given as monotherapy to patients with relapsed/refractory NHL and CLL.

Condition Intervention Phase
Non Hodgkins Lymphoma
Chronic Lymphocytic Leukaemia
Drug: ONO-4059
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose-escalation Study to Investigate the Safety and Tolerability of ONO-4059 Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma and/or Chronic Lymphocytic Leukaemia.

Resource links provided by NLM:

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • 1. Safety and tolerability and the incidence of dose limiting toxicities (DLTs). DLTs will be assessed within the first 28 days from receiving the first dose of ONO-4059. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Frequency, severity and relatedness of AEs.

Secondary Outcome Measures:
  • 1. Pharmacokinetic/pharmacodynamic assessments [ Time Frame: During 1 cycle = 28 days ] [ Designated as safety issue: No ]
    Pharmacodynamics of ONO-4059 (ie, drug occupancy of Btk and effect on biological markers of B cell function.

  • 2. Tumour response [ 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 as defined by guidelines on NHL and CLL, duration of response, CR rate, PFS, OS

Estimated Enrollment: 92
Study Start Date: August 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Drug: ONO-4059
ONO-4059 QD or BID. Start dose is 20mg.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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 identifier: NCT01659255

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
Ono Pharmaceutical Co. Ltd
Study Director: Clinical Department Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT01659255     History of Changes
Other Study ID Numbers: ONO-4059POE001 
Study First Received: July 6, 2012
Last Updated: August 17, 2015
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:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on February 09, 2016