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NCT00434174 Clinical Trial

Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Non Small Cell Lung Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00434174
Other study ID # CRAD001C2112
Secondary ID 2006-002759-34
Status Completed
Phase Phase 1
First received
Last updated
Start date December 2006
Est. completion date December 2010

Study information
Verified date December 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Everolimus
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
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

Locations
Country Name City State
Australia Novartis Investigative Site Camperdown New South Wales
Australia Novartis Investigative Site Melbourne Victoria
Belgium Novartis Investigative Site Leuven
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Koeln

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Belgium,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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