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| Sponsors and Collaborators: |
AstraZeneca KuDOS Pharmaceuticals Limited |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00515866 |
Purpose
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Neoplasms |
Drug: KU-0059436 (AZD2281)(PARP inhibitor) Drug: Gemcitabine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours |
| Estimated Enrollment: | 95 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2010 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Gemcitabine + KU-0059436
|
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Drug: Gemcitabine
intravenous injection
|
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: AstraZeneca Cancer Study Locator Service | 877-400-4656 | astrazeneca@emergingmed.com |
| Contact: AstraZeneca Clinical Information Center | 1-800-236-9933 | information.center@astrazeneca.com |
| United States, New York | |
| Research Site | Recruiting |
| New York, New York, United States | |
| United States, Tennessee | |
| Research Site | Recruiting |
| Nashville, Tennessee, United States | |
| Germany, Bavaria | |
| Research Site | Active, not recruiting |
| Munich, Bavaria, Germany | |
| United Kingdom | |
| Research Site | Recruiting |
| Oxford, United Kingdom | |
| Research Site | Recruiting |
| London, United Kingdom | |
| Principal Investigator: | Howard A Burris III, MD | The Sarah Cannon Cancer Center |
More Information
| Study ID Numbers: | D0810C00005, KU36-29 |
| Study First Received: | August 13, 2007 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00515866 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
|
Advanced pancreatic cancer Poly (ADP ribose) polymerases Advanced Solid Tumours |
|
Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Antiviral Agents Immunosuppressive Agents |
Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
|
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |