| General information |
| Database: | DB00809 |
| Objective: | Thisphase 2 trial (ClinicalTrials.gov identifier NCT00548093) assessed the efficacy, safety, and impact on healthrelated quality of life of dacomitinib (PF00299804), an irreversible tyrosine kinase inhibitor (TKI) of human epidermal growth factor receptors (EGFR)/HER1, human epidermal growth factor receptor 2, and HER4, in patients with KRAS wildtype non small cell lung cancer (non small cell lung cancer). |
| Authors: | Reckamp KL, et al |
| Title: | a phase 2 trial of dacomitinib (PF00299804), an oral, irreversible panHER (human epidermal growth factor receptor) inhibitor, in patients with advanced non small cell lung cancer after failure of prior chemotherapy and erlotinib. |
| Journal: | Cancer. |
| Year: | 2014 |
| PMID: | 24501009 |
| Trial Design |
| Clinical Trial Id: | NCT00548093 |
| Agent: | dacomitinib
|
| Target: | Epidermal growth factor receptor, Proto oncogene proteinc mdm2, Erbb2 tyrosine kinase receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II trial |
| Key Patients Feature: | Patients with advanced non small cell lung cancer, progression on 1 or 2 regimens of chemotherapy and erlotinib, KRAS wildtype or known EGFRsensitizing mutant tumor, and Eastern Cooperative Oncology Group performance status of 0 to 2 |
| Biomarker: | KRAS/EGFR mutation status |
| Biomark Analysis: | Median progression free survival was 12 weeks overall (n = 66) and 18 weeks (n = 26) for patients with EGFR mutationpositive tumors. |
| Control Group Info: | single arm |
| Treatment Info: | pts received 45 mg of dacomitinib once daily continuously in 21day cycles. |
| Primary End Point: | efficacy, safety, and impact on healthrelated quality of life |
| Secondary End Point: | NA |
| Patients Number: | 66 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 5.2% for overall patients; adenocarcinoma was 5%; 6% for patients with nonadenocarcinoma. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 12 weeks overall (n = 66) and 18 weeks (n = 26) for patients with EGFR mutationpositive tumors. |
| Median OS A vs. C: | 57 weeks |
| Adverse Event(agent arm): | Common events included diarrhea (85%), dermatitis acneiform (68%), dry skin (38%), fatigue (38%), exfoliative rash (24%), stomatitis (24%), decreased appetite (23%), and pruritus (23%). |
| Conclusions: | Dacomitinib demonstrated preliminary activity and acceptable tolerability in heavily pretreated patients, and may offer benefit in molecularly defined patient subsets. |