multiple myeloma [MM], non-Hodgkin lymphoma [NHL], acute myeloid leukemia [AML], acute lymphoid leukemia [ALL], chronic myeloid leukemia [CML]
Conditions
Interventions
investigational material(s)
Generic name etc : OPB-51602
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materia
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML. 2) Patients who are responsive or have relapsed following standard treatment 3) Patients capable of providing written informed consent 4) Japanese patients age 20 to 75 years (inclusive) at time of informed consent 5) ECOG performance status score of 0-1 6) Life expectancy of at least 3 months 7) Adequate vital organ function 8) Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration
Exclusion criteria
Exclusion criteria: 1) Patients with other primary malignant tumors 2) Symptomatic CNS involvement 3) Ongoing or active infection, or complication that is not controllable by medication or other means 4) Complication of uncontrolled cardiac disease 5) Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period 6) Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety of OPB-51602 1 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the efficacy of OPB-51602 | — |
Outcome results
None listed