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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00456833 |
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Date of registration:
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04/04/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy
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Scientific title:
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A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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248 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00456833 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Denmark
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France
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Russian Federation
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmeceuticals |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Age over 18 years
- Advanced Non Small Cell Lung Cancer which is not responding to chemotherapy treatment
including either cisplatin or carboplatin
- Only 1-2 previous chemotherapy regimens for advanced disease
- More than 2 weeks from previous surgery, radiation or chemotherapy
- Ability to perform normal daily functions
Exclusion criteria:
- Chronic steroid treatment
- Prior treatment with EGFR inhibitors
- Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth
ulcers, eye conditions or other severe medical conditions
- Other cancers within the past 2 years
- Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria
may apply
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non Small Cell Lung Cancer
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Intervention(s)
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Drug: RAD001
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Drug: erlotinib
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Primary Outcome(s)
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Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.
[Time Frame: first 28 days of combined treatment]
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Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1
[Time Frame: at baseline and after 8 weeks of treatment]
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Secondary Outcome(s)
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Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression
[Time Frame: at baseline, monthly until month 4 then q2months until progression]
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Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue
[Time Frame: Dec 2009]
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Phase 2: Safety and steady state drug levels evaluated monthly
[Time Frame: Monthly]
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Secondary ID(s)
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2004-003017-16
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CRAD001C2111
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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