Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
- Registration Number
- NCT00511082
- Lead Sponsor
- Otsuka Beijing Research Institute
- Brief 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
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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.
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Patients are receiving another investigational agent or who have received another investigational agent within 6 months.
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Patients are receiving concurrent chemotherapy, biologic agents, or radiotherapy.
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Patients are receiving concurrent administration of warfarin.
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NHL or MM patients who are candidates for autologous stem cell transplantation are excluded from the study.
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Patients with other primary malignancy except squamous or basal cell skin cancer or cervical cancer in situ.
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Patients with acute lymphoblastic lymphoma/leukaemia, POEMS syndrome or plasma cell leukaemia.
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Lymphoma patients with symptomatic CNS involvement.
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Patients with uncontrolled intercurrent illness.
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Known HIV-positive/AIDS patients.
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Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period.
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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
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group OPB-31121 Investigational Medicinal Product: OPB-31121 25-mg tablet, 100-mg tablet Dose: OPB-31121 50, 100, 200, 400, 600, 800, and 1000 mg Dosage regimen: ingestion with water after breakfast Treatment period: 4 weeks Mode of Administration: oral administration of OPB-31121 once daily
- Primary Outcome Measures
Name Time Method Safety and tolerability 4 weeks
- Secondary Outcome Measures
Name Time Method 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria 4 weeks
Trial Locations
- Locations (1)
Department of Clinical Oncology, Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong