Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Phase 1

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Everolimus; Drug: Pemetrexed

• Registration Number: NCT00434174
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-13
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
everolimus + Pemetrexed - daily	Everolimus	Daily treatment
everolimus + Pemetrexed - daily	Pemetrexed	Daily treatment
everolimus + Pemetrexed - weekly	Everolimus	Weekly treatment
everolimus + Pemetrexed - weekly	Pemetrexed	Weekly treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Koeln, Germany