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Safety of Everolimus and Pemetrexed in Lung Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00434174
First received: February 9, 2007
Last updated: December 18, 2012
Last verified: December 2012

February 9, 2007
December 18, 2012
December 2006
December 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy
Complete list of historical versions of study NCT00434174 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
  • 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)
Not Provided
Not Provided
 
Safety of Everolimus and Pemetrexed in Lung Cancer Patients
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • 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 - daily
    Daily treatment
    Interventions:
    • Drug: Everolimus
    • Drug: Pemetrexed
  • Experimental: everolimus + Pemetrexed - weekly
    Weekly treatment
    Interventions:
    • Drug: Everolimus
    • Drug: Pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2010
December 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Germany
 
NCT00434174
CRAD001C2112, 2006-002759-34
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
Novartis
December 2012

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