Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Multicenter, Open-label, Non-randomized, Dose-escalation, Therapeutic Exploratory Trial to Evaluate the Safety and Efficacy of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406574
• Other study ID #: 252-11-001
• Secondary ID: JapicCTI-111546
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 28, 2011
• Last updated: May 21, 2015
• Start date: July 2011
• Est. completion date: March 2014

Study information

• Verified date: May 2015
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is:

Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patients with histopathologically or clinically confirmed diagnosis of hepatocellular carcinoma

• Patients with Child-Pugh classification A or B

• Patients unresponsive to standard therapy or for whom standard therapy is intolerable, or for whom there is no appropriate therapy

• Patients who are able to take oral medication

• Patients age 20 to 79 years (inclusive) at time of informed consent

• Patients with an ECOG performance status score of 0-2

• Patients have the eligible organ function.

Exclusion Criteria:

• Patients with a primary malignant tumor

• Patients with a history of liver transplant

• Patients with brain metastases

• Patients with a complication of uncontrolled

• Patients with a psychiatric disorder that might cause difficulty in obtaining informed consent or in conducting the trial

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• OPB-31121
Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
• OPB-31121 phase2
Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects With Treatment Emergent Adverse Events	Treatment emergent adverse events observed during outcome measure time frame.	From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)	Yes
Primary	Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%.; DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ? 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ? 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ? 8 consecutive days 6) Same AEs causing interruption of IMP administration twice	From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)	Yes
Secondary	Best Overall Response	Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.	From first dose of study medication up to 28 weeks	No