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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:
There is no limit to number of prior regimens. Prior erlotinib therapy is allowed.
Adequate hematologic, hepatic and renal parameters: leukocytes =/>3,000/ul, absolute neutrophil count
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
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: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00640978 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pancreatic Cancer Advanced Pancreatic Cancer Unresectable Metastatic RAD001 |
Everolimus Erlotinib OSI-774 Erlotinib Hydrochloride Tarceva |
Erlotinib Everolimus Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Immunosuppressive Agents |
Protein Kinase Inhibitors Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Endocrine Gland Neoplasms |
Everolimus Erlotinib Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors |
Protein Kinase Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Pancreatic Diseases Endocrine Gland Neoplasms |