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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis OSI Pharmaceuticals |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00640978 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: RAD001 Drug: Erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Erlotinib + RAD001
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Drug: RAD001
30 mg PO Weekly x 4 Weeks
Drug: Erlotinib
150 mg PO Daily x 28 Days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susie Bullock, RN | 713-792-1633 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Milind Javle, MD |
Principal Investigator: | Milind Javle, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Milind Javle, MD/Associate Professor ) |
Study ID Numbers: | 2007-0666 |
Study First Received: | March 17, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00640978 |
Health Authority: | United States: Food and Drug Administration |
Pancreatic Cancer Advanced Pancreatic Cancer RAD001 Everolimus |
Erlotinib OSI-774 Erlotinib Hydrochloride Tarceva |
Everolimus Erlotinib Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms |
Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
Enzyme Inhibitors Protein Kinase Inhibitors Immunosuppressive Agents Pharmacologic Actions |