NCT00374140

Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ahmad Tarhini · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be administered orally at a dose of 10 mg daily.

Detailed description

This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. Patients may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no prior therapy with an m-TOR inhibitor. RAD001 will be administered orally at a dose of 10 mg daily. A cycle will be defined as 3 weeks of study drug administration, and patients will have tumor measurements every 2 cycles. Study participation will continue until disease progression or intolerable toxicities. In addition, in patients who consent, archival tumor tissue (paraffin block from original biopsy) will be collected for research purposes.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	RAD001 (everolimus)	10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-12-01
• Completion: 2012-06-01
• First posted: 2006-09-08
• Last updated: 2017-10-19
• Results posted: 2014-02-27

Locations

19 sites across 1 country: United States