Non Small Cell Lung Cancer Clinical Trial
Official title:
A Two-step Phase 1 Study Investigating the Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients Not Treated Previously With Systemic Therapy
This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab
Status | Completed |
Enrollment | 69 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 23 Years to 76 Years |
Eligibility |
Inclusion criteria: - Age over 18 years - Advanced Non Small Cell Lung Cancer (Stage IIIB/IV) - Ability to perform normal daily functions Exclusion criteria: - Chronic steroid treatment - Prior treatment with chemotherapy for advanced lung cancer - Prior treatment with mTOR inhibitors - Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions - Known sensitivity to platinum compounds, taxanes or bevacizumab - Other cancers within the past 5 years - Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Novartis Investigative Site | Adelaide | South Australia |
Australia | Novartis Investigative Site | Heidelberg | Victoria |
Germany | Novartis Investigative Site | Essen | |
Germany | Novartis Investigative Site | Heidelberg | |
United States | U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office | Dallas | Texas |
United States | MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc. | Houston | Texas |
United States | LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center | New Orleans | Louisiana |
United States | Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114 | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Australia, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate | Ever 3 months or once a critical DLT occurs | Yes | |
Secondary | Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1) | End of step 1 | Yes | |
Secondary | Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2) | End of Step 2 | Yes | |
Secondary | PK parameters derived from PK profiles of treatment drugs alone and in combination | End of Step 1 and Step 2 | No | |
Secondary | Best overall response - measured by CT/MRI scan every 6-8 week | Every 6-8 week | No |
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