Phase 2 Completed N=23 Treatment

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

Hepatocellular Carcinoma

Source: ClinicalTrials.gov NCT01406574 ↗

Enrolled (actual)

Serious AEs

8.7%

Results posted

Jun 2015

Primary outcomePrimary: Subjects With Treatment Emergent Adverse Events — 23 participants

Summary

The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjects With Treatment Emergent Adverse Events	23	—
PRIMARY Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	0; 0; 1; 4	—
SECONDARY Best Overall Response	0; 6; 9; 8	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01406574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.