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
• Start date: December 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

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

External Links

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