Clinical trial · Interventional
Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)
An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)
NCT01009593CI-TRIAL-00007990terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See termination reason in detailed description
Summary
Brief summary (as posted)
The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Digestive System Diseases | — | UNRESOLVED | — |
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma Non-resectable | — | UNRESOLVED | — |
| Hepatocellular Carcinoma Recurrent | — | UNRESOLVED | — |
| Liver Diseases | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABT-869
- interventionNames
- Drug: ABT-869
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- From randomization until patient death; assessed monthly
Secondary outcomes (2)
- measure
- Time To Progression (TTP)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Histologic or cytologic diagnosis with unresectable or metastatic HCC * Child Pugh Class A * ECOG performance status 0-1 * Adequate hematologic, hepatic, and renal function Exclusion Criteria * Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC * Prior local therapy (including liver-directed therapy) within 4 weeks from entry * Untreated brain or meningeal metastases * Current treatment on another clinical trial * Pregnancy or breastfeeding
References
Publications (2)
- DERIVEDKolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27. PMID 34052255
- DERIVEDCainap C, Qin S, Huang WT, Chung IJ, Pan H, Cheng Y, Kudo M, Kang YK, Chen PJ, Toh HC, Gorbunova V, Eskens FA, Qian J, McKee MD, Ricker JL, Carlson DM, El-Nowiem S. Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clin Oncol. 2015 Jan 10;33(2):172-9. doi: 10.1200/JCO.2013.54.3298. Epub 2014 Dec 8. PMID 25488963