Status:
UNKNOWN
An Open-Label Phase-1 Study of OPB-31121 in Patients With Advanced Solid Tumors
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Ability to understand and willingness to sign written informed consent document for participation in the trial and for analysis of genotypes CYP2C9 and NAT2
- No chemotherapy, radiotherapy, surgery, or immunotherapy within 4 weeks prior to study entry and recovered from any prior toxicity
- Exclusion criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00657176
Start Date
March 1 2008
End Date
June 1 2009
Last Update
April 18 2008
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744