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| Sponsor: | Samsung Medical Center |
|---|---|
| Information provided by: | Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT00944463 |
Purpose
The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: Gemcitabine and simvastatin Drug: Gemcitabine plus Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Gemcitabine+simvastatin: Experimental
Gemcitabine and simvastatin
|
Drug: Gemcitabine and simvastatin
Gemcitabine and simvastatin
|
|
Gemcitabine+Placebo: Placebo Comparator
Gemcitabine plus Placebo
|
Drug: Gemcitabine plus Placebo
Gemcitabine plus Placebo
|
Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.
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| Contact: YoungSuk Park, M.D. | 822-3410-3459 | psy27hmo@skku.edu |
| Contact: YangHee Kim, RN | 822-3410-6483 | juragee.kim@samsung.com |
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Young Suk Park, M.D.,Ph.D 82-2-3410-3459 psy27hmo@skku.edu | |
| Principal Investigator: | Young Suk Park, M.D.,Ph.D. | Samsung Medical Center, Seoul, Korea |
More Information
| Responsible Party: | Samsung Medical Center ( Young Suk Park M.D., Ph.D. ) |
| Study ID Numbers: | 2008-07-065 |
| Study First Received: | July 21, 2009 |
| Last Updated: | July 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00944463 History of Changes |
| Health Authority: | Korea: Food and Drug Administration |
|
advanced pancreatic cancer gemcitabine simvastatin placebo |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Neoplasms by Site Therapeutic Uses Gemcitabine Endocrine Gland Neoplasms Digestive System Neoplasms |
Simvastatin Antilipemic Agents Endocrine System Diseases Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases |