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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

August 2, 2007
July 1, 2008
December 2007
September 2009   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00511082 on ClinicalTrials.gov Archive Site
1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
  • 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

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
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma(NHL)
  • Multiple Myeloma(MM)
Drug: OPB-31121
Patients will receive OPB-31121 administered orally, once daily for 4 weeks.
Experimental: Treatment group
Intervention: Drug: OPB-31121
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
December 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Shii Man, M.D & Ph.D. +86-10-85182966 ext 8001 mans@obri.otsuka.com
Hong Kong
 
NCT00511082
252-07-801-01, 252-07-801-01
Yes
Otsuka Beijing Research Institute
Otsuka Beijing Research Institute
Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Kenny IK Lei, M.D Department of Clinical Oncology, Prince of Wales Hospital
Otsuka Beijing Research Institute
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP