Entry Detail
| General information | |
| Database: | DB00115 |
| Objective: | This trial was designed to determine the safety and efficacy of lapatinib in hepatocellular carcinoma. |
| Authors: | BekaiiSaab T, et al |
| Title: | A multiinstitutionalphase II study of the efficacy and tolerability of lapatinib in patients with advanced hepatocellular carcinomas. |
| Journal: | Clin Cancer Res. |
| Year: | 2009 |
| PMID: | 19737952 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | lapatinib |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 |
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, singlearm, multicenterphase II study |
| Key Patients Feature: | histologically confirmed unresectable advanced hepatocellular carcinoma and measurable disease per RECIST, less than and equal to 1 prior systemic anticancer therapy; |
| Biomarker: | expression of human epidermal growth factor receptor 2/NEU/CEP17 and status of downstream signal pathway proteins(did not correlate with survival) |
| Biomark Analysis: | they did not find evidence of human epidermal growth factor receptor 2/NEU somatic mutations. PTEN, PAKT, and P70S6K expression did not correlate with survival |
| Control Group Info: | single arm |
| Treatment Info: | 1, 500 mg/day administered orally in 28day cycles |
| Primary End Point: | ORR as defined by RECIST criteria. |
| Secondary End Point: | toxicity, OS, assessment of mutations of EGFR and human epidermal growth factor receptor 2/neu genes and measurement of expression of proteins in signaling pathways relevant to lapatinib including human epidermal growth factor receptor 2/neu, PTEN, PAkt, and P70S6K. |
| Patients Number: | 26 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | No objective responses were observed. Ten (40%) patients had stable disease as their best response including six (23%) with stable disease lasting >120 days. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.9 |
| Median OS A vs. C: | 12.6, patients who developed a rash had a borderline statistically significant longer survival. |
| Adverse Event(agent arm): | Most common toxicities were diarrhea (73%), nausea (54%), and rash (42%). |
| Conclusions: | Lapatinib is welltolerated but seems to benefit only a subgroup of patients for whom predictive molecular or clinical characteristics are not yet fully defined. |