Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 224
Healthy volunteers: no

Brief summary:
The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.

Detailed description:

Arms:
arm 1: Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration arm 2: Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study

Interventions: intervention 1: Axitinib (AG-013736) intervention 2: Best Supportive Care intervention 3: Placebo intervention 4: Best Supportive Care
Intervention descriptions: intervention 1: Axitinib \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID intervention 2: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life. intervention 3: Placebo \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID intervention 4: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.

Protocol document: