A Phase 1 interventional study of Everolimus in Small-Cell Lung Cancer, sponsored by Novartis Pharmaceuticals. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Drug: Everolimus
Drug: Everolimus
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.
Also known as: RAD001
Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1
Time frame: Day 21
Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen
Time frame: within 6 cycles (Day 126)
PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles
Time frame: During the first 6 cycles
Overall tumor response
Time frame: Every 6-8 weeks
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals