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Phase 2 Study of TAC-101 Combined With Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone in Japanese Patients With Advanced Hepatocellular Carcinoma

NCT00667628 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-09-19

Study results available
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Summary

The purpose of this study is to determine whether TAC-101 combined with Transcatheter Arterial Chemoembolization (TACE) is more effective than TACE alone in slowing tumor activity in patients with advanced hepatocellular carcinoma. The study is also looking at the safety of TAC-101 in combination with TACE.

Conditions

Interventions

DRUG

TAC-101

Participants received TAC-101 20 mg (2 x 10-mg formulated tablets) administered orally every day with approximately 8 oz. water within 1 hour following a morning meal for 14 days followed by a 7-day recovery period, repeated every 21 days.

DRUG

Placebo

Participants received placebo (two matching tablets) at same frequency and duration of active treatment.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Taiho Central, MD · Taiho Oncology, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-24
Primary Completion
2009-12-22
Completion
2009-12-22

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00667628 on ClinicalTrials.gov