Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00434174

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

9.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Everolimus Drug: Pemetrexed	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: everolimus + Pemetrexed - daily Daily treatment	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. Other Names: RAD001 Affinitor Drug: 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
Experimental: everolimus + Pemetrexed - weekly Weekly treatment	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. Other Names: RAD001 Affinitor Drug: 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

Arm

Intervention/Treatment

Experimental: everolimus + Pemetrexed - daily

Daily treatment

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.

Other Names:

RAD001

Affinitor

Drug: 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

Experimental: everolimus + Pemetrexed - weekly

Weekly treatment

Drug: Everolimus

Other Names:

RAD001

Affinitor

Drug: 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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Camperdown	New South Wales	Australia	2050
2	Novartis Investigative Site	Melbourne	Victoria	Australia	3002
3	Novartis Investigative Site	Leuven		Belgium	3000
4	Novartis Investigative Site	Hamburg		Germany	20246
5	Novartis Investigative Site	Koeln		Germany	50924