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

A Phase 1, Open-Label, Non-Randomized Study of OPB-31121 in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Unknown
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: OPB-31121

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yung-Jue Bang, PhD; Phone Number: 82-2-2072-2390; Email: bangyj@snu.ac.kr
• Study Contact Backup: Name: Hanna Lee, Bachelor; Phone Number: 82-2-2072-0603; Email: life1025@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hanna Lee, Bachelor; Phone Number: +82-2-2072-0603; Email: life1025@naver.com
    • Principal Investigator: Yung-Jue Bang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose	Cycle 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	Cycle 1
Safety and dose-limiting toxicity	Duration of Study
Antitumor effect	Duration of study

Collaborators and Investigators

• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yung-Jue Bang, PhD, Division of Hematology and Medical Oncology, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): March 1, 2009
• Study Completion (Anticipated): June 1, 2009

Study Registration Dates

• First Submitted: April 9, 2008
• First Submitted That Met QC Criteria: April 11, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Estimate): April 18, 2008
• Last Update Submitted That Met QC Criteria: April 17, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 252-KOA-0701