Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT01009593
Status:
TERMINATED
Last Update Posted:
2012-09-10
First Post:
2009-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)
Sponsor:
Organization:
Raw JSON
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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': '25488963', 'type': 'DERIVED', 'citation': 'Cainap 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Histologic or cytologic diagnosis with unresectable or metastatic HCC\n* Child Pugh Class A\n* ECOG performance status 0-1\n* Adequate hematologic, hepatic, and renal function\n\nExclusion Criteria\n\n* Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC\n* Prior local therapy (including liver-directed therapy) within 4 weeks from entry\n* 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