Entry Detail
| General information | |
| Database: | DB00095 |
| Objective: | Dual inhibition of SRC and EGFRdependent pathways may overcome acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFRTKIs) for patients with lung adenocarcinoma with EGFR mutations. The SRC inhibitor dasatinib demonstrates antitumor activity in gefitinibresistant cells lines and xenografts. |
| Authors: | Johnson ML, et al |
| Title: | a phase I/II study combining erlotinib and dasatinib for non small cell lung cancer. |
| Journal: | Oncologist. |
| Year: | 2011 |
| PMID: | 21623279 |
| Trial Design | |
| Clinical Trial Id: | NCI grant CA (13034301) |
| Agent: | dasatinib |
| Target: | Protooncogene tyrosineprotein kinase SRC Abl Protooncogene tyrosineprotein kinase LCK Protooncogene tyrosineprotein kinase Fyn |
| Cancer Type: | lung cancer |
| Cancer Subtype: | lung adenocarcinoma and EGFR mutations |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | Dasatinib+ Erlotinib |
| Study Type: | a phase II trial |
| Key Patients Feature: | Patients with lung adenocarcinoma meeting consensus criteria for acquired resistance were eligible |
| Biomarker: | all EGFR mutations (exon 19 deletions, L858R and T790M substitutions);MET amplification |
| Biomark Analysis: | Dasatinib has no activity in patients with EGFRmutant lung adenocarcinoma with acquired resistance to erlotinib and gefitinib. |
| Control Group Info: | dasatinib alone |
| Treatment Info: | Seven days after discontinuing erlotinib or gefitinib therapy, patients began dasatinib at a dose of 70 mg twice daily.patients were evaluated by CT scan at four weeks, eight weeks, and at eightweek intervals. |
| Primary End Point: | RR, TTP, toxicity |
| Secondary End Point: | NA |
| Patients Number: | 21 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | they observed no complete or partial responses (0% observed rate, 95% confidence interval: 018%). |
| Disease Control Rate: | NA |
| Median Time to Progression: | 0.5 months (range, 0.21.8 months) in patients treated with dasatinib and 0.9 months (range, 0.45 months) for patients treated with dasatinib and erlotinib in combination. |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Dasatinib has no activity in patients with EGFRmutant lung adenocarcinoma with acquired resistance to erlotinib and gefitinib. |