Multiple Myeloma, Non-Hodgkin's Lymphoma(NHL)
Conditions
Brief summary
* To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients Non-Hodgkin's Lymphoma(NHL) or Multiple Myeloma(MM) * To determine the potential dose-limiting toxicities and maximum-tolerated dose in patients treated with OPB-31121 * To determine the pharmacokinetics and anti-tumor efficacy of OPB-31121 in patients
Detailed description
The study is designed as a single-center,open-label,phase 1 dose-escalation study to assess the safety,tolerability,pharmacokinetics, and anti-tumor efficacy of OPB-31121 in patients with relapsed or refractory NHL or MM.
Interventions
DRUGOPB-31121
100-mg tablet Dose: OPB-31121 50, 100, 200, 400, 600, 800, and 1000 mg Dosage regimen: ingestion with water after breakfast Treatment period: 4 weeks Mode of Administration: oral administration of OPB-31121 once daily
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Otsuka Beijing Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have relapsed or refractory NHL histologically confirmed. * Relapsed or refractory NHL or MM patients must have experienced treatment failure. * Chinese patients aged 18 years or older at the time of giving informed consent. * Performance status score of 0-2 according to the incriteria of he Eastern Cooperative Oncology Group(ECOG) * Life expectancy of longer than 3 months. * Patients must have adequate vital organ function. * Patients are willing to comply with the visit schedules of the hospitalization and outpatient clinic. * Patients with prior chemotherapy, immunotherapy, cytokines therapy, major surgery, and radiotherapy to the index lesion must have been completed for a minimum period of 4 weeks and recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration. * Patients with systemic corticosteroid therapy (\>10 mg prednisone or equivalent) must have been completed for a minimum of 1 weeks and recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration. * Patients with prior stem cell transplantation must be at least 8 weeks and have recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration.
Exclusion criteria
* Patients are receiving another investigational agent or who have received another investigational agent within 6 months. * Patients are receiving concurrent chemotherapy, biologic agents, or radiotherapy. * Patients are receiving concurrent administration of warfarin. * NHL or MM patients who are candidates for autologous stem cell transplantation are excluded from the study. * Patients with other primary malignancy except squamous or basal cell skin cancer or cervical cancer in situ. * Patients with acute lymphoblastic lymphoma/leukaemia, POEMS syndrome or plasma cell leukaemia. * Lymphoma patients with symptomatic CNS involvement. * Patients with uncontrolled intercurrent illness. * Known HIV-positive/AIDS patients. * Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period. * Patients will not or are unable to use appropriate contraceptive methods during the study period and for at least 6 months after completion of the study * Patients need to receive any of the following treatments or therapeutic agents during the study period: * Anti-cancer drugs other than the study drug * Systemic corticosteroid therapy (\>10 mg prednisone or equivalent) * Radiotherapy as primary therapy * Immunotherapy * Surgical therapy * CYP3A4 and CYP2C9 enzyme inducers or inhibitors,or substrates, and CYP2B6, CYP2C8, and CYP2D6 substrates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria | 4 weeks |
Countries
Hong Kong
Outcome results
None listed