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
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