A Study of TAC-101 in Combination With TACE Versus TACE Alone in Asian Patients With Advanced Hepatocellular Carcinoma

NCT00756782 | Withdrawn Phase 2

• 1 other identifier: TAC101-204
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of TAC-101 after Transcatheter Arterial Chemoembolization (TACE) in patients with advanced, unresectable hepatocellular carcinoma (HCC) who are being scheduled for TACE.

Conditions

Advanced Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• radiologically proven progression-free survival (PFS)

  Tumor Imaging assessments will be conducted at screening/baseline within 14 days prior to first TACE; every 8 weeks during treatment within 14 days prior to first TACE and every 8 weeks during follow-up period within 14 days prior to first TACE.

Secondary Outcomes (9)

• Overall survival (OS)

  Survival status obtained every 8 weeks during imaging follow-up period, from first TACE, patients contacted every 12 weeks until death or for at least 3 yrs after randomization of the last patient.

• Time to appearance of remote new lesions (TTNLr)

  Tumor Imaging assessments will be conducted at screening/baseline within 14 days prior to first TACE; every 8 weeks during treatment within 14 days prior to first TACE and every 8 weeks during follow-up period within 14 days prior to first TACE.

• Objective tumor response rate (ORR) according to RECIST criteria (CR + PR)

  Tumor Imaging assessments will be conducted at screening/baseline within 14 days prior to first TACE; every 8 weeks during treatment within 14 days prior to first TACE and every 8 weeks during follow-up period within 14 days prior to first TACE.

• Effects on the plasma levels of alpha-fetoprotein (AFP and AFP-L3)

  Blood samples for AFP and AFP-L3assessment obtained at Screening/ Baseline; every 8 weeks after first TACE during the treatment period; at the end of the treatment period; and every 8 weeks (± 2 weeks) from first TACE during imaging f/up period.

• Number of post-randomization TACE procedures

  The number of post-randomization TACE procedures per patient in the double-blind treatment period patient will be counted every 8 weeks during treatment from first TACE.

Study Arms (2)

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

Drug: TAC-101

B

PLACEBO COMPARATOR

Patients will receive placebo (two matching tablets) at same frequency and duration of active treatment

Drug: Placebo

Interventions

TAC-101 DRUG

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.

A

Placebo DRUG

Patients will receive placebo (two matching tablets) at same frequency and duration of active treatment

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has an HCC diagnosis by histology (can not have a mixed tumor type such as HCC and cholangiocarcinoma) OR by the following non-invasive criteria observed either within 14 days prior to first TACE or in the past.
• One imaging technique (CT scan or magnetic resonance imaging \[MRI\] both with unenhanced plus hepatic arterial phase and portal venous phases) showing characteristic features in a focal lesion \> 20 mm with arterial vascularization, or
• Two dynamic imaging techniques (CT scan, MRI with unenhanced plus hepatic arterial phase and portal venous phases) showing characteristic features coincidentally in a focal lesion 10-20 mm with arterial vascularization.
• Is TACE naïve or has received the most recent TACE procedure, which showed complete necrosis after treatment, at least 120 days before signing ICF.
• Eligible to receive TACE and being scheduled to receive TACE.
• Is ≥ 18 years of age.
• Is not amenable to treatment with curative surgery, transplant, or percutaneous ablation, including RFA, percutaneous ethanol injection therapy (PEIT) and percutaneous microwave coagulation therapy (PMCT).
• Have at least 1 measurable lesion that is ≥10 mm in size. Measurable lesions must be confirmed nodular type (not including only infiltration type) which demonstrated substantial hypervascularity by CT scan or MRI both with unenhanced plus hepatic arterial phase and portal venous phases. All measurable lesions must be targeted by the first TACE in this study
• If there are ≥ 4 intrahepatic lesions, at least 1 must be ≥10 mm and all lesions must be \<100 mm.
• If there are \< 4 intrahepatic lesions, at least one must be ≥ 30 mm and all lesions must be \<100 mm.
• No vascular invasion in main trunk and first order branch of portal vein or other large vessels (hepatic vein or inferior vena cava).
• No extrahepatic tumor spread
• Absence of extrahepatic abdominal tumors must be confirmed.
• Has adequate organ function as defined by the following criteria:
• White blood cell (WBC) count \> 3,000/mm3

You may not qualify if:

• \- Patients will be excluded from participation in the study if any of the following conditions are observed before undergoing the first TACE procedure:
• Has only infiltration type of HCC.
• Has extrahepatic metastasis of HCC including regional lymph node metastases.
• Has had systemic chemotherapy (eg, sorafenib, doxorubicin), immunotherapy, or biologic therapy or radiotherapy for HCC, or treatment with TAC-101.
• Received treatment with any of the following within the specified time frame:
• Any major surgical procedure within 28 days prior to signing the ICF
• Any red blood cell or thrombocyte transfusion, treatment with blood component preparation, albumin preparation, Granulocyte-Colony Stimulating Factor (G-CSF), or erythropoietin within 14 days prior to signing the ICF
• Any intra-arterial chemotherapy (transcatheter injection) using lipiodol for HCC performed within 119 days prior to signing ICF.
• Any local therapy such as alcohol injection, radiofrequency/ultrasound ablation, intraarterial chemotherapy (transcatheter arterial injection) for HCC performed within 28 days prior to signing the ICF
• Any investigational agent within 28 days prior to signing the ICF
• Has ascites, pleural effusions or pericardial fluid refractory to diuretic therapy.
• Has clinical symptoms of hepatic encephalopathy.
• Has active or uncontrolled clinically serious infection excluding chronic hepatitis.
• Has a history of gastrointestinal (GI) bleeding in last 3 months.
• Has previous or concurrent malignancy except for in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence for at least 3 years prior to the study.

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

TAC 101

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Fabio Benedetti, MD

  Taiho Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 4, 2024

Record last verified: 2024-08