This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. All proposed dose levels in this study can be given as a combination of these dose strengths. Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed.
Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Cologne, Germany
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
Time frame: Over 18 weeks of combination treatment
Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)
Time frame: Over 18 weeks of combination treatment
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Novartis Investigative Site
Hamburg, Germany