Phase I Study of ONO-4059 Given as Monotherapy in Patients With Relapsed/Refractory NHL and CLL
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 24 cycles of treatment.
Non Hodgkins Lymphoma
Chronic Lymphocytic Leukaemia
|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.|
- 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 - 24 months ] [ Designated as safety issue: Yes ]Frequency, severity and relatedness of AEs.
- 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 (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
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
ONO-4059 QD up to maximum 24 cycles (1 cycle = 28 days). Start dose is 20mg.
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.
|Contact: Ono Pharma UK Ltd|
|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|
|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|
|Plymouth, United Kingdom, PL6 8DH|
|Contact: Rule +44 (0)1752 517505|
|Study Director:||Clinical Department||Ono Pharmaceutical Co. Ltd|