Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
- 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
- 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
- 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
- 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.
- 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
- 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
- Surgical therapy
- CYP3A4 and CYP2C9 enzyme inducers or inhibitors,or substrates, and CYP2B6,
CYP2C8, and CYP2D6 substrates.