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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00657176
• Other study ID #: 252-KOA-0701
• Status: Recruiting
• Phase: Phase 1
• First received: April 9, 2008
• Last updated: April 17, 2008
• Start date: March 2008
• Est. completion date: June 2009

Study information

• Verified date: April 2008
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: Yung-Jue Bang, PhD
• Phone: 82-2-2072-2390
• Email: bangyj[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		Cycle 1	Yes
Secondary	Safety and dose-limiting toxicity		Duration of Study	Yes
Secondary	Pharmacokinetics		Cycle 1	No
Secondary	Antitumor effect		Duration of study	No