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

NCT00511082 | Completed Phase 1 DMC

• 1 other identifier: 252-07-801-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  4 weeks

Secondary Outcomes (1)

• 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria

  4 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Drug: OPB-31121

Interventions

OPB-31121 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

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Kenny IK Lei, M.D

  Department of Clinical Oncology, Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)