| General information |
| Database: | DB01009 |
| Objective: | The mammalian target of rapamycin (mTOR) pathway is dysregulated in smallcell lung cancer (SCLC) and everolimus is an oral mTOR inhibitor |
| Authors: | Sun JM, et al |
| Title: | a phase1b study of everolimus plus paclitaxel in patients with smallcell lung cancer. |
| Journal: | Br J Cancer. |
| Year: | 2013 |
| PMID: | 23963141 |
| Trial Design |
| Clinical Trial Id: | NCT01079481 |
| Agent: | everolimus
|
| Target: | Serine/threonineprotein kinase mTOR
|
| Cancer Type: | smallcell lung cancer |
| Cancer Subtype: | smallcell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | everolimus + paclitaxel |
| Study Type: | a phaseIb study |
| Key Patients Feature: | previously treated SCLC patients. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | everolimus was given at the levels of 2.5, 5, or 10 mg once daily in combination with paclitaxel (175 mg m(2)) once every 3 weeks in previously treated SCLC patients. |
| Primary End Point: | to determine the maximum tolerated dose of everolimus |
| Secondary End Point: | NA |
| Patients Number: | 21 |
| Trial Results |
| DLT_MTD: | Out of 11 evaluable patients treated with everolimus at the level of 5 mg, 1 patient experienced doselimiting toxicity (DLT) of grade 4 febrile neutropenia and grade 3 thrombocytopenia. The other two DLTs (grade 4 thrombocytopenia and grade 3 hyperglycemia) occurred in two out of three patients receiving everolimus 10 mg. |
| Objective Response Rate: | 28% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Among 21 enrolled patients, common drugrelated adverse events were anaemia, neutropenia, thrombocytopenia, pain, hyperglycemia, and stomatitis. |
| Conclusions: | Everolimus showed an acceptable safety profile and preliminary antitumour activity at the dose of 5 mg once daily when combined with 3weekly paclitaxel 175 mg m(2) in patients with SCLC. |