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Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Cancer

Intervention: Everolimus (Drug); Pemetrexed (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Novartis, Study Chair, Affiliation: Novartis

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.

Clinical Details

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

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

Secondary outcome: 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)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative Site, Leuven 3000, Belgium

Novartis Investigative Site, Hamburg 20246, Germany

Novartis Investigative Site, Koeln 50924, Germany

Novartis Investigative Site, Camperdown, New South Wales 2050, Australia

Novartis Investigative Site, Melbourne, Victoria 3002, Australia

Additional Information

Starting date: December 2006
Last updated: December 18, 2012

Page last updated: August 23, 2015

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