Phase 2 Study of TAC-101 Combined With Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone in Japanese Patients With Advanced Hepatocellular Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00667628|
Recruitment Status : Terminated (Terminated due to safety concerns.)
First Posted : April 28, 2008
Results First Posted : April 15, 2022
Last Update Posted : April 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Hepatocellular Carcinoma||Drug: TAC-101 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||April 24, 2008|
|Actual Primary Completion Date :||December 22, 2009|
|Actual Study Completion Date :||December 22, 2009|
Placebo Comparator: Placebo
Participants were administered with placebo tablets matching to TAC-101 orally, every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) treatment recovery period. Repeated every 21 days cycle up to new lesions were observed or the participant met a treatment discontinuation criterion.
Participants received placebo (two matching tablets) at same frequency and duration of active treatment.
Participants were administered with TAC-101 tablets, 20 milligram per day (mg/day) orally for every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) recovery period (21-day Cycle). Repeated every 21 days cycle up to new lesions were observed or the participant met a treatment discontinuation criterion.
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.
- Time to Appearance of New Lesions (TTNL) [ Time Frame: From randomization (within 14 days prior to first TACE) assessed every 9 weeks after first TACE to date of appearance of a new lesion or until cut-off date (22-Dec-2009) (up to approximately 20 months) ]TTNL was defined as the time from the date of randomization to the date of appearance of a new lesion. Participants who had no appearance of new lesions had their TTNL censored at the date of their last tumor assessment.
- Overall Survival (OS) [ Time Frame: From randomization (within 14 days prior to first TACE) assessed every 9 weeks after first TACE until cut-off date of 22 Dec 2009 (up to approximately 20 months) ]OS was defined as the time from date of randomization to date of death. Participants who were still alive at the time of analysis had their survival time censored at the last date known to be alive.
- Progression-Free Survival (PFS) [ Time Frame: From randomization (within 14 days prior to first TACE) assessed every 9 weeks after first TACE until cut-off date of 22 Dec 2009 (up to approximately 20 months) ]PFS was defined as the time from date of randomization to the date of disease progression (radiological, only).
- Objective Tumor Response Rate (ORR) [ Time Frame: From randomization (within 14 days prior to first TACE) assessed every 9 weeks after first TACE until cut-off date of 22 Dec 2009 (up to approximately 20 months) ]ORR was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<)10 millimeters (mm). PR was defined as at least a 30 percent decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters.
- Change From Baseline in Plasma Levels of Tumor Marker Alpha-fetoprotein (AFP) [ Time Frame: Baseline, End of treatment (last dose of study medication, i.e., approximately 7 months) ]AFP was known as a tumor marker for advanced hepatocellular carcinoma (HCC) and was recognized as useful for following the course of HCC. Changes in serum AFP parallel the clinical course of HCC, where elevations can precede clinical deterioration and tumor recurrence.
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: From first dose of study drug up to 30 days after last dose of study drug or until the start of new anti-tumor therapy, whichever was earlier (up to approximately 8.5 months) ]Any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study drug was considered an adverse event (AE). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs: AEs that occur from the initiation of any study treatment administration, and do not necessarily have a causal relationship to the use of the study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667628
|Study Director:||Taiho Central, MD||Taiho Oncology, Inc.|