CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
lapatinib ditosylate +1 moredrug
Likely dose
Lapatinib ditosylate orally (specific dose not specified in eligibility or arms)AI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed surgically unresectable biliary cancer (gallbladder, ampullary, intra/extrahepatic bile duct) OR surgically unresectable HCC not candidates for percutaneous ethanol injection or RFA
  • ✓Measurable disease: ≥20 mm with conventional imaging or ≥10 mm with spiral CT; if prior TACE/ethanol/RFA, new lesions must be present in liver if no other sites of disease
  • ✓Life expectancy >12 weeks
  • ✓ECOG performance status ≤2 (Karnofsky ≥60%)
Key exclusion· 8
  • ✕Prior treatment with EGFR-targeting therapies
  • ✕Child-Pugh score B or C
  • ✕Known brain metastases
  • ✕PT prolongation >4 seconds above ULN (unless on warfarin)

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

Search/NCT00101036
NCT00101036Phase 2Completed
CompareCT.gov

A Phase II Study of GW572016 (Lapatanib) in Locally Advanced or Metastatic Hepato-Biliary Cancers

National Cancer Institute (NCI)·interventional·Posted Jan 10, 2005·Updated Apr 20, 2018

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 57 participants across 1 site.

Detailed Summary

This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic biliary tract or liver cancer that cannot be removed by surgery. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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 PostedJan 10, 2005
Enrollment StartNov 1, 2004
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 21.5 years ago

Interventions

lapatinib ditosylatedrug

Given PO

laboratory biomarker analysisother

Correlative studies