phase 1 study of opb-31121 in patients with relapsed or refractory non-hodgkin's lymphoma or multiple myeloma

Conditions: Non-Hodgkin's Lymphoma(NHL); Multiple Myeloma

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

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.

Eligibility criteria:
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.