| General information |
| Database: | DB01003 |
| Objective: | Dacomitinib (PF00299804), an irreversible panhuman epidermal growth factor receptor ([HER]1/EGFR, HER2, and HER4) tyrosine kinase inhibitor, demonstrated antitumor activity in theystern patients with non small cell lung cancer (non small cell lung cancer) at a dose of 45 mg once daily. they report data from a phase I/II, multicenter, openlabel study of Korean patients with refractory KRAS wildtype adenocarcinoma non small cell lung cancer (defined as patients with evidence of disease progression during or within 6 months of treatment with chemotherapy and gefitinib or erlotinib). |
| Authors: | Park K, et al |
| Title: | Safety and efficacy of dacomitinib in korean patients with KRAS wildtype advanced non small cell lung cancer refractory to chemotherapy and erlotinib or gefitinib: a phase I/II trial. |
| Journal: | J Thorac Oncol. |
| Year: | 2014 |
| PMID: | 25521398 |
| Trial Design |
| Clinical Trial Id: | NCT00553254 |
| Agent: | dacomitinib
|
| Target: | Epidermal growth factor receptor, Proto oncogene proteinc mdm2, Erbb2 tyrosine kinase receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | KRAS wildtype advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase I/II, multicenter, openlabel study |
| Key Patients Feature: | Korean patients with refractory KRAS wildtype adenocarcinoma non small cell lung cancer (defined as patients with evidence of disease progression during or within 6 months of treatment with chemotherapy and gefitinib or erlotinib). |
| Biomarker: | KRAS wildtype |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | the phase I dosefinding portion identified the recommendedphase II dose (RP2D) in Korean patients, evaluated safety, and characterized the pharmacokinetics of dacomitinib. In the phase II portion, patients received dacomitinib at the RP2D. |
| Primary End Point: | progression free survival at 4 months (PFS4m). |
| Secondary End Point: | NA |
| Patients Number: | 12 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 17.1% (95% CI, 7.232.1) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 15.4 weeks (95% CI, 9.717.6) |
| Median OS A vs. C: | 46.3 weeks (95% CI, 32.7not reached) |
| Adverse Event(agent arm): | The most common treatmentrelated adverse events were dermatitis acneiform (81.8%), diarrhea (78.2%), paronychia (63.6%), stomatitis (45.5%), and palmar-plantar erythrodysesthesia syndrome (32.7%) |
| Conclusions: | Dacomitinib was well tolerated and had antitumor activity in Korean patients with non small cell lung cancer who had previously progressed on chemotherapy and an epidermal growth factor receptor tyrosine kinase inhibitor |