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Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Everolimus

Pemetrexed

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Lung cancer, Non small cell lung cancer, NSCLC, RAD001, Everolimus, Afinitor, Pemetrexed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

everolimus + Pemetrexed - daily

everolimus + Pemetrexed - weekly

Arm Description

Daily treatment

Weekly treatment

Outcomes

Primary Outcome Measures

Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.

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)

Full Information

NCT ID

NCT00434174

First Posted

February 9, 2007

Last Updated

December 17, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00434174

Brief Title

Safety of Everolimus and Pemetrexed in Lung Cancer Patients

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 Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

Lung cancer, Non small cell lung cancer, NSCLC, RAD001, Everolimus, Afinitor, Pemetrexed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

everolimus + Pemetrexed - daily

Arm Type

Experimental

Arm Description

Daily treatment

Arm Title

everolimus + Pemetrexed - weekly

Arm Type

Experimental

Arm Description

Weekly treatment

Intervention Type

Drug

Intervention Name(s)

Everolimus

Other Intervention Name(s)

RAD001, Affinitor

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Novartis

Official's Role

Study Chair

Facility Information:

Facility Name

Novartis Investigative Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50924

Country

Germany

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4423

Description

Results for CRAD001C2112 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

Safety of Everolimus and Pemetrexed in Lung Cancer Patients

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