Safety of Everolimus and Pemetrexed in Lung Cancer Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00434174

First received: February 9, 2007

Last updated: December 18, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 9, 2007

Last Updated Date

December 18, 2012

Start Date ^ICMJE

December 2006

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy

Change History

Complete list of historical versions of study NCT00434174 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non Small Cell Lung Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: everolimus + Pemetrexed - daily
Daily treatment
Interventions:
- Drug: Everolimus
- Drug: Pemetrexed
Experimental: everolimus + Pemetrexed - weekly
Weekly treatment
Interventions:
- Drug: Everolimus
- Drug: Pemetrexed

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Belgium, Germany

Administrative Information

NCT Number ^ICMJE

NCT00434174

Other Study ID Numbers ^ICMJE

CRAD001C2112, 2006-002759-34

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals
Study Chair:	Novartis	Novartis

Information Provided By

Novartis

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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