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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
Novartis OSI Pharmaceuticals |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00640978 |
Purpose
Primary Objectives:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
Erlotinib + RAD001
|
Drug: RAD001
30 mg PO Weekly x 4 Weeks
Drug: Erlotinib
150 mg PO Daily x 28 Days
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
|
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 |