Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Novartis

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Everolimus; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434174

2006-002759-34

CRAD001C2112

Details and patient eligibility

About

This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

everolimus + Pemetrexed - daily

Experimental group

Description:

Daily treatment

Treatment:

Drug: Pemetrexed

Drug: Everolimus

everolimus + Pemetrexed - weekly

Experimental group

Description:

Weekly treatment

Treatment:

Drug: Pemetrexed

Drug: Everolimus