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

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Beijing Research Institute
• Collaborator: Otsuka Pharmaceutical Co., Ltd.

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.