Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma

Pfizer

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Other: Best Supportive Care; Drug: Axitinib (AG-013736); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01210495

2010-021590-37 (EudraCT Number)

A4061058

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced or metastatic HCC
• Failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and brivanib.
• Child-Pugh Class A or B (score 7 only) disease.

Exclusion criteria

• Prior treatment of advanced HCC with more than one prior first-line systemic therapy.
• Any prior local therapy within 2 weeks of starting the study treatment.
• Presence of hepatic encephalopathy and/or clinically relevant ascites.
• Presence of main portal vein invasion by HCC.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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224 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

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

Treatment:

Other: Best Supportive Care

Drug: Axitinib (AG-013736)

Other: Best Supportive Care

B

Placebo Comparator group

Description:

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

Treatment:

Other: Best Supportive Care

Drug: Placebo

Other: Best Supportive Care