An Open-Label Phase-1 Study of OPB-31121 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657176
Recruitment Status : Unknown
Verified April 2008 by Korea Otsuka Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 14, 2008
Last Update Posted : April 18, 2008
Information provided by:
Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
This is an open-label, non-randomized, single-center, dose-escalation study in patients with advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in patients with advanced solid tumors to evaluate the recommended dose for use in subsequent studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: OPB-31121 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Non-Randomized Study of OPB-31121 in Patients With Advanced Solid Tumors
Study Start Date : March 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : June 2009

Intervention Details:
    Drug: OPB-31121
    • 100mg tablet
    • oral administration, Qd

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: Cycle 1 ]

Secondary Outcome Measures :
  1. Safety and dose-limiting toxicity [ Time Frame: Duration of Study ]
  2. Pharmacokinetics [ Time Frame: Cycle 1 ]
  3. Antitumor effect [ Time Frame: Duration of study ]

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Histologically confirmed solid tumor refractory to standard therapy or for which there is no standard therapy
  2. Age: more than 19 years
  3. ECOG performance status: less than 2
  4. Life expectancy of longer than 3 months
  5. Adequate vital organ function as follows:

    • Bone marrow function

      • neutrophils: more than 1,500 per microliter
      • platelets: more than 75,000 per microliter
      • hemoglobin: more than 10.0g per deciliter
    • Hepatic function

      • AST and ALT: less than 2.5 x institutional upper limit normal
      • serum total bilirubin: less than 2.5 x institutional ULN
    • Renal function

      • Serum creatinine: less than 1.5 x institutional ULN
  6. Capable of swallowing OPB-31121 tablets
  7. Ability to understand and willingness to sign written informed consent document for participation in the trial and for analysis of genotypes CYP2C9 and NAT2
  8. No chemotherapy, radiotherapy, surgery, or immunotherapy within 4 weeks prior to study entry and recovered from any prior toxicity

Exclusion criteria:

  1. Symptomatic CNS metastasis
  2. Uncontrolled concurrent illness, including active infection, heart failure, angina pectoris, and cardiac arrhythmia
  3. Psychiatric illness that would limit compliance with study requirements
  4. Pregnant or breast-feeding women and women of childbearing potential who cannot or will not use effective contraceptive measures
  5. Administration of another investigational agent within 6 months prior to study entry
  6. Use of CYP3A4 and CYP2C9 inducers, inhibitors, or substrates, and CYP2B6, CYP2C8 and CYP2D6 substrates
  7. Hyperlipidemia:

    Total cholesterol:more than 300 milligram per deciliter or Triglycerides:

    more than 2.5 x institutional ULN

  8. Abnormal thyroid function: Hypothyroidism or hyperthyroidism of grade 2 or higher (graded according to the NCI-CTCAE)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657176

Contact: Yung-Jue Bang, PhD 82-2-2072-2390
Contact: Hanna Lee, Bachelor 82-2-2072-0603

Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Hanna Lee, Bachelor    +82-2-2072-0603   
Principal Investigator: Yung-Jue Bang, PhD         
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Yung-Jue Bang, PhD Division of Hematology and Medical Oncology, Seoul National University Hospital

Responsible Party: Sol Han / Clinical Research Associate, Clinical Research Team Identifier: NCT00657176     History of Changes
Other Study ID Numbers: 252-KOA-0701
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: April 18, 2008
Last Verified: April 2008