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Safety of Everolimus and Pemetrexed in Lung Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00434174
First Posted: February 13, 2007
Last Update Posted: December 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: Everolimus Drug: Pemetrexed Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 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) [ Time Frame: Over 18 weeks of combination treatment ]

Enrollment: 48
Study Start Date: December 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus + Pemetrexed - daily
Daily treatment
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.

Other Names:
  • RAD001
  • Affinitor
Drug: 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
Experimental: everolimus + Pemetrexed - weekly
Weekly treatment
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.

Other Names:
  • RAD001
  • Affinitor
Drug: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434174


Locations
Australia, New South Wales
Novartis Investigative Site
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Novartis Investigative Site
Melbourne, Victoria, Australia, 3002
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Germany
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Koeln, Germany, 50924
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00434174     History of Changes
Other Study ID Numbers: CRAD001C2112
2006-002759-34
First Submitted: February 9, 2007
First Posted: February 13, 2007
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Lung cancer
Non small cell lung cancer
NSCLC
RAD001
Everolimus
Afinitor
Pemetrexed

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Everolimus
Sirolimus
Pemetrexed
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors