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

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

• 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

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.

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.