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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Ono Pharmaceutical Co. Ltd
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT01659255
First received: July 6, 2012
Last updated: July 2, 2014
Last verified: June 2013
  Purpose

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. ONO-4059 will be administered orally, once daily(QD)as a flat dose, for up to maximum 36 cycles of treatment.


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: 6 - 36 months ] [ 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
ONO-4059
Drug: ONO-4059
ONO-4059 QD up to maximum 36 cycles (1 cycle = 28 days). 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Ono Pharma UK Ltd

Locations
France
CHRU - Hopital Claude HURIEZ Recruiting
Lille, France, 59037
Contact: Morschhauser    +33 3 20444290      
Centre hospitalier Lyon Sud Recruiting
Lyon, France, 69495
Contact: Salles    +33 4 7886 4307      
CHU St Eloi Recruiting
Montpellier, France, 34295
Contact: Cartron    +33-4-67338079      
United Kingdom
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
Contact: Fegan    +44 (0)2920 745654      
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Dyer    +44-(0)116-252-5589      
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Rule    +44 (0)1752 517505      
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Clinical Department Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01659255     History of Changes
Other Study ID Numbers: ONO-4059POE001
Study First Received: July 6, 2012
Last Updated: July 2, 2014
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, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on October 01, 2014