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

Otsuka

Status and phase

Unknown

Phase 1

Conditions

Non-Hodgkin's Lymphoma(NHL)

Multiple Myeloma(MM)

Treatments

Drug: OPB-31121

Study type

Interventional

Funder types

Industry

Identifiers

NCT00511082

252-07-801-01

Details and patient eligibility

About

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

Full description

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.

To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients NHL or 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

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.