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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
Novartis OSI Pharmaceuticals |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00640978 |
Purpose
The goal of this clinical research study is to learn if the combination of RAD001 and erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this drug combination will also be studied.
Primary Objectives:
-Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001 in patients who have received previous treatment for advanced pancreatic cancer.
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: RAD001 Drug: Erlotinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer |
| Enrollment: | 16 |
| Study Start Date: | March 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Erlotinib + RAD001
Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
|
Drug: RAD001
30 mg orally weekly for 4 weeks
Other Name: Everolimus
Drug: Erlotinib
150 mg by mouth daily for 28 Days
Other Names:
|
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 | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00640978 History of Changes |
| Other Study ID Numbers: | 2007-0666 |
| Study First Received: | March 17, 2008 |
| Results First Received: | July 22, 2011 |
| Last Updated: | August 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Pancreatic Cancer Advanced Pancreatic Cancer Unresectable Metastatic RAD001 |
Everolimus Erlotinib OSI-774 Erlotinib Hydrochloride Tarceva |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Everolimus Sirolimus Erlotinib Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |