Overview

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.