Entry Detail
| General information | |
| Database: | DB00097 |
| Objective: | to determine the efficacy of secondline dasatinib in patients with chemosensitive (relapse or progression > or =90 days after completing firstline therapy) small cell lung cancer. |
| Authors: | Miller AA, et al |
| Title: | a phase II study of dasatinib in patients with chemosensitive relapsed small cell lung cancer (Cancer and Leukemia Group B 30602). |
| Journal: | J Thorac Oncol. |
| Year: | 2010 |
| PMID: | 20087228 |
| Trial Design | |
| Clinical Trial Id: | CALGB 30602(not mentioned) |
| Agent: | Dasatinib |
| Target: | Protooncogene tyrosineprotein kinase SRC Abl Protooncogene tyrosineprotein kinase LCK Protooncogene tyrosineprotein kinase Fyn |
| Cancer Type: | smallcell lung cancer |
| Cancer Subtype: | Chemosensitive Relapsed Small Cell Lung Cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II Study |
| Key Patients Feature: | Patients with measurable disease; performance status 0 to 1; no more than one prior platinumbased chemotherapy regimen; and adequate hematologic, hepatic, and renal function were eligible |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received dasatinib on an outpatient basis at a dose of 70 mg by mouth twice daily. Three weeks constituted one cycle of treatment. Treatment was continued daily until disease progression or intolerable toxicity. |
| Primary End Point: | the efficacy of secondline dasatinib in chemosensitive SCLC and PFS at 6 weeks of treatment. |
| Secondary End Point: | the ORR, PF and OS, and toxicity of dasatinib in this patient population. |
| Patients Number: | 45 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | No objective response was recorded among the 43 eligible and treated patients |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Among the initial 27 patients, only 13 instances of PFS more than and equal to 6 weeks were observed. |
| Median OS A vs. C: | With a median follow up time of 7.1 months, median estimated OS and PFS times for the 43 eligible and treated patients were 17.0 and 5.9 weeks, respectively. |
| Adverse Event(agent arm): | Toxicity was generally mild to moderate: grade 3 events of >5% frequency included fatigue, and pleural and pericardial effusions; and no grade 4 or 5 events were encountered |
| Conclusions: | Dasatinib did not reach our specified efficacy criteria in this clinical setting, and the study was terminated. |