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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Highlands Oncology Group
Fayetteville, Arkansas, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
MD Anderson Cancer Center
Houston, Texas, United States
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
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Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States
Novartis Investigative Site
Paris, France