An Open-label, Randomized, Multi-center, Phase II Study to Compare the Safety and Efficacy of TKI258 Versus Sorafenib as First-line Treatment in Adult Patients With Advanced Hepatocellular Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- dovitinib
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Overall Survival - Overall Survival
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of advanced Hepatocellular Carcinoma (HCC) according to the AASLD Guidelines
- •Advance HCC Stage B and C according to BCLC staging classification
- •Child Pugh A
- •At least one measurable lesion as assessed by CT or MRI
- •ECOG PS of 0 or 1
- •Adequate bone marrow, liver, and renal function
Exclusion Criteria
- •Prior systemic therapy for HCC
- •Brain metastases
- •Active bleeding (including variceal bleeding as the result of esophageal varices) Patients who have received a liver transplant or are awaiting an immediate transplant
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
TKI258
capsule
Intervention: dovitinib
Sorafenib
tablet
Intervention: sorafenib
Outcomes
Primary Outcomes
Overall Survival - Overall Survival
Time Frame: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.
The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed
Secondary Outcomes
- Time to Tumor Progression (Tumor Assessment)(Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.)
- Time to Definitive Deterioration in ECOG Performance Status (PS)(Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first)
- Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258(Week 1 day 1, week 4 day 5)
- Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258(Week 1 day 1, week 4 day 5)
- Disease Control Rate (Tumor Assessment)(Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.)
- Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258(Week 1 day 1, week 4 day 5)