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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00401778 |
This is a Phase 1b randomized, pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 to evaluate clinical response as assessed metabolically by changes in PET scan (50% reduction in standardized uptake value SUV) at baseline and immediately prior to surgery. The safety profile of RAD001 will also be evaluated and the effect of this treatment on survival (both progression-free and overall survival) following surgery and adjuvant chemotherapy (cisplatin and docetaxel).
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: RAD001 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 1b Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 60 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2015 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
RAD001 5 mg/day for 21 days sequentially.
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Drug: RAD001
Patients will be assigned to one of three treatment arms with RAD001 doses of 5, 7.5 and 10 mg/day for 21 days sequentially taken orally in tablet form.
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2: Active Comparator
RAD001 7.5 mg/day for 21 days sequentially.
|
Drug: RAD001
Patients will be assigned to one of three treatment arms with RAD001 doses of 5, 7.5 and 10 mg/day for 21 days sequentially taken orally in tablet form.
|
3: Active Comparator
RAD001 10 mg/day for 21 days sequentially.
|
Drug: RAD001
Patients will be assigned to one of three treatment arms with RAD001 doses of 5, 7.5 and 10 mg/day for 21 days sequentially taken orally in tablet form.
|
This is a Phase 1b randomized, pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 to evaluate clinical response as assessed metabolically by changes in PET scan (50% reduction in standardized uptake value SUV) at baseline and immediately prior to surgery. The safety profile of RAD001 will also be evaluated and the effect of this treatment on survival (both progression-free and overall survival) following surgery and adjuvant chemotherapy (cisplatin and docetaxel).
New agents and regimens are urgently needed for lung cancer treatment. With the development of novel agents and small molecules designed to curtail the aggressive aspects of this disease, some progress has been realized. However, much more effort and insight will be required for further real gains to be made. We propose that studying the mTOR axis, known to be abnormal in non-small cell lung cancer (NSCLC), and translating that knowledge into therapeutic adjustments can lead to meaningful advances in lung cancer treatment.
Approximately 60 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fadlo Khuri, MD | 888-946-7447 |
United States, Georgia | |
Emory University Winship Cancer Institute | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Principal Investigator: Fadlo Khuri, MD |
Principal Investigator: | Fadlo Khuri, MD | Emory University Winship Cancer Institute |
Responsible Party: | Winship Cancer Institute ( Fadlo Khuri, MD ) |
Study ID Numbers: | 1341-2004 |
Study First Received: | November 17, 2006 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00401778 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Lung Cancer |
Everolimus Thoracic Neoplasms Immunologic Factors Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Immunosuppressive Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Everolimus Respiratory Tract Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |