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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Otsuka Beijing Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:
NCT00511082
First received: August 2, 2007
Last updated: July 1, 2008
Last verified: July 2008
  Purpose
  • 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

Condition Intervention Phase
Non-Hodgkin's Lymphoma(NHL)
Multiple Myeloma(MM)
Drug: OPB-31121
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Otsuka Beijing Research Institute:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group Drug: OPB-31121
Patients will receive OPB-31121 administered orally, once daily for 4 weeks.

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.

  • 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511082

Contacts
Contact: Shii Man, M.D & Ph.D. +86-10-85182966 ext 8001 mans@obri.otsuka.com

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Shatin, N.T., Hong Kong, SAR, Hong Kong
Contact: Kenny IK Lei, M.D    (852) 2632 2137    kennylei@cuhk.cuhk.edu.hk   
Sponsors and Collaborators
Otsuka Beijing Research Institute
Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Kenny IK Lei, M.D Department of Clinical Oncology, Prince of Wales Hospital
  More Information

No publications provided

Responsible Party: Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT00511082     History of Changes
Other Study ID Numbers: 252-07-801-01, 252-07-801-01
Study First Received: August 2, 2007
Last Updated: July 1, 2008
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014