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

July 1, 2008 updated by: Otsuka Beijing Research Institute
  • 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

Study Overview

Status

Unknown

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Hong Kong, SAR
      • Shatin, N.T., Hong Kong, SAR, Hong Kong
        • Recruiting
        • Department of Clinical Oncology, Prince of Wales Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Patients will receive OPB-31121 administered orally, once daily for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kenny IK Lei, M.D, Department of Clinical Oncology, Prince of Wales Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

August 2, 2007

First Submitted That Met QC Criteria

August 2, 2007

First Posted (Estimate)

August 3, 2007

Study Record Updates

Last Update Posted (Estimate)

July 2, 2008

Last Update Submitted That Met QC Criteria

July 1, 2008

Last Verified

July 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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