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.
18 Years
N/A
Both
Non Hodgkins Lymphoma, Chronic Lymphocytic Leukaemia
Trial Information
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.
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.
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Description:
Frequency, severity and relatedness of AEs.
Outcome Time Frame:
6 - 12 months
Safety Issue:
Yes
Principal Investigator
Clinical Department
Investigator Role:
Study Director
Investigator Affiliation:
Ono Pharmaceutical Co. Ltd
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
ONO-4059POE001
NCT ID:
NCT01659255
Start Date:
August 2012
Completion Date:
January 2015
Related Keywords:
- Non Hodgkins Lymphoma
- Chronic Lymphocytic Leukaemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|
