CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
lapatinib ditosylate +1 moredrug
Likely dose
Dose not specified in protocolAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed unresectable hepatocellular carcinoma with Child-Pugh score ≤7 OR biliary tract carcinoma
  • ✓Measurable disease: ≥20 mm by conventional imaging OR ≥10 mm by spiral CT
  • ✓Fresh or paraffin-embedded tumor tissue available for analysis
  • ✓ECOG performance status 0-1 (Karnofsky 60-100%)
Key exclusion· 7
  • ✕Known brain metastases
  • ✕Prior EGFR-targeting therapy
  • ✕Unstable angina, cardiac arrhythmia, or other uncontrolled cardiac disease
  • ✕Active or ongoing infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00107536
NCT00107536Phase 2Completed
CompareCT.gov

A Phase II Study of Efficacy and Tolerability of GW572016 in Patients With Advanced Hepatocellular and Biliary Carcinomas

National Cancer Institute (NCI)·interventional·Posted Apr 6, 2005·Updated Apr 29, 2015

In Brief

A Phase 2 clinical trial evaluating lapatinib ditosylate and laboratory biomarker analysis for Adult Primary Hepatocellular Carcinoma and 7 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed Summary

Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 6, 2005
Enrollment StartOct 1, 2005
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 21.2 years ago

Interventions

lapatinib ditosylatedrug

laboratory biomarker analysisother

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