Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

Study Overview
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Brief Summary
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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
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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. To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients NHL or 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

Official Title
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Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

Conditions
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Non-Hodgkin's Lymphoma(NHL), Multiple Myeloma(MM)

Intervention / Treatment
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* Drug: OPB-31121


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Drug: OPB-31121<br>* Patients will receive OPB-31121 administered orally, once daily for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria |  | 4 weeks |