Phase 2
N=165
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01232296 ↗Enrolled (actual)
165
Serious AEs
45.7%
Results posted
Dec 2015
Primary outcome: Primary: Overall Survival - Overall Survival — 33; 39.4 Weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dovitinib (Drug); sorafenib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival - Overall Survival |
33; 39.4 | — |
| SECONDARY Time to Tumor Progression (Tumor Assessment) |
17.6; 17.9 | — |
| SECONDARY Disease Control Rate (Tumor Assessment) |
0; 1; 5; 8; 42; 44 | — |
| SECONDARY Time to Definitive Deterioration in ECOG Performance Status (PS) |
22.3; 21.3 | — |
| SECONDARY Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258 |
326.25; 364.04 | — |
| SECONDARY Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258 |
6; 5.9 | — |
| SECONDARY Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258 |
5774.69; 6493.99 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01232296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.