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Safety of Everolimus and Pemetrexed in Lung Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT00434174
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE February 9, 2007
First Posted Date  ICMJE February 13, 2007
Last Update Posted Date December 21, 2020
Study Start Date  ICMJE December 2006
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2007)
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2007)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Everolimus and Pemetrexed in Lung Cancer Patients
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: everolimus + Pemetrexed - daily
    Daily treatment
    Interventions:
    • Drug: Everolimus
    • Drug: Pemetrexed
  • Experimental: everolimus + Pemetrexed - weekly
    Weekly treatment
    Interventions:
    • Drug: Everolimus
    • Drug: Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2012)
48
Original Enrollment  ICMJE
 (submitted: February 9, 2007)
60
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00434174
Other Study ID Numbers  ICMJE CRAD001C2112
2006-002759-34
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
PRS Account Novartis
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP