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Sponsors and Collaborators: |
Taiho Pharma USA, Inc. Quintiles |
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Information provided by: | Taiho Pharma USA, Inc. |
ClinicalTrials.gov Identifier: | NCT00667628 |
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.
Condition | Intervention | Phase |
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Advanced Hepatocellular Carcinoma |
Drug: TAC-101 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of TAC-101 in Combination With Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone in Japanese Patients With Advanced Hepatocellular Carcinoma |
Estimated Enrollment: | 116 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Patients will receive 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
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Drug: TAC-101
Patients will receive 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.
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B: Placebo Comparator
Patients will receive placebo (two matching tablets) at same frequency and duration of active treatment
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Drug: Placebo
Patients will receive placebo (two matching tablets) at same frequency and duration of active treatment
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Advanced metastatic hepatocellular carcinoma (HCC) is not treatable by surgical approaches or locoregional therapies such as hepatic artery hemoembolization or radiofrequency ablation (RFA) which are effective in controlling localized tumors. Transcatheter arterial chemoembolization (TACE) is the most commonly performed procedure in the treatment of unresectable liver tumors for selected patients. The TACE procedure delivers highly concentrated drugs to the tumor itself and arrests blood flow. Most patients will have intrahepatic recurrence of their tumors following TACE. Studies of TAC-101, a synthetic retinoid, indicate that although TAC-101 may not induce tumor regression, it appears to have a stabilizing effect, prolonging survival over what was expected historically. This study is designed as a randomized, double-blind, placebo-controlled, parallel-group, phase 2 study in patients with advanced HCC who have undergone a TACE procedure, which will be conducted at multiple sites in Japan, to determine if administration of TAC-101 will enhance the benefits of the TACE procedure.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study and before undergoing the first TACE procedure of this study:
Has an HCC diagnosis by histology or by the following non-invasive criteria observed either at enrollment or in the past.
Must have lesions in the liver that are confirmed nodular type with demonstrated substantial hypervascularity by CT scan or MRI both with unenhanced plus hepatic arterial phase and portal venous phases performed prior to first TACE in this study with the following tumor features:
Exclusion Criteria:
Patients will be excluded from participation in the study if any of the following conditions are observed before undergoing the first TACE procedure:
Contact: Takahito Okubo | 81-3-3293-2296 | |
Contact: Peter Urrea | 609-750-5300 |
Study Director: | Peter Urrea | Taiho Pharma USA, Inc. |
Responsible Party: | Taiho Pharma USA, Inc. ( Peter Urrea/Senior VP, Clinical and Regulatory Affairs ) |
Study ID Numbers: | TAC101-203 |
Study First Received: | April 24, 2008 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00667628 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular |
Gastrointestinal Neoplasms Hepatocellular Carcinoma Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |