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

NCT ID: NCT00511082

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-07-31

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.

Conditions

Non-Hodgkin's Lymphoma(NHL); Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

OPB-31121

Intervention Type: DRUG

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

Interventions

OPB-31121

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenny IK Lei, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Oncology, Prince of Wales Hospital

Locations

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

252-07-801-01

Identifier Type: -

Identifier Source: org_study_id