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

NCT00657176 | Unknown Phase 1

• 1 other identifier: 252-KOA-0701
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  Cycle 1

Secondary Outcomes (3)

• Safety and dose-limiting toxicity

  Duration of Study

• Pharmacokinetics

  Cycle 1

• Antitumor effect

  Duration of study

Interventions

OPB-31121 DRUG

* 100mg tablet * oral administration, Qd

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed solid tumor refractory to standard therapy or for which there is no standard therapy
• Age: more than 19 years
• ECOG performance status: less than 2
• Life expectancy of longer than 3 months
• 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
• Capable of swallowing OPB-31121 tablets

You may not qualify if:

• Symptomatic CNS metastasis
• Uncontrolled concurrent illness, including active infection, heart failure, angina pectoris, and cardiac arrhythmia
• Psychiatric illness that would limit compliance with study requirements
• Pregnant or breast-feeding women and women of childbearing potential who cannot or will not use effective contraceptive measures
• Administration of another investigational agent within 6 months prior to study entry
• Use of CYP3A4 and CYP2C9 inducers, inhibitors, or substrates, and CYP2B6, CYP2C8 and CYP2D6 substrates
• Hyperlipidemia:
• Total cholesterol:more than 300 milligram per deciliter or Triglycerides:
• more than 2.5 x institutional ULN
• Abnormal thyroid function: Hypothyroidism or hyperthyroidism of grade 2 or higher (graded according to the NCI-CTCAE)

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Study Officials

• Yung-Jue Bang, PhD

  Division of Hematology and Medical Oncology, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung-Jue Bang, PhD

CONTACT

82-2-2072-2390; bangyj@snu.ac.kr

Hanna Lee, Bachelor

CONTACT

82-2-2072-0603; life1025@naver.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 14, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 18, 2008

Record last verified: 2008-04

Locations

KR (1)