Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Study Overview
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Brief Summary
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This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.

Official Title
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A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Everolimus
* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Lung cancer Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer Adequate bone marrow function Adequate liver function Adequate renal function Negative serum pregnancy test Exclusion criteria: History of another primary malignancy in the last 5 years Having recently received an investigational drug Having recently received major surgery of wide field radiotherapy Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators Severe or uncontrolled medical conditions Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: everolimus + Pemetrexed - daily<br>Daily treatment | Drug: Everolimus<br>* 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.<br>* Other names: Affinitor;Drug: Pemetrexed<br>* 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<br>|
| Experimental: everolimus + Pemetrexed - weekly<br>Weekly treatment | Drug: Everolimus<br>* 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.<br>* Other names: Affinitor;Drug: Pemetrexed<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate. |  | Over 18 weeks of combination treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | Over 18 weeks of combination treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Non small cell lung cancer, NSCLC, RAD001, Everolimus, Afinitor, Pemetrexed