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

NCT ID: NCT00657176

Last Updated: 2008-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OPB-31121

* 100mg tablet
* oral administration, Qd

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Clinical Research Team

Principal Investigators

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Yung-Jue Bang, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Hematology and Medical Oncology, Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yung-Jue Bang, PhD

Role: CONTACT

Phone: 82-2-2072-2390

Email: [email protected]

Hanna Lee, Bachelor

Role: CONTACT

Phone: 82-2-2072-0603

Email: [email protected]

Facility Contacts

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Hanna Lee, Bachelor

Role: primary

Other Identifiers

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252-KOA-0701

Identifier Type: -

Identifier Source: org_study_id