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Sponsored by: |
Gloucester Pharmaceuticals |
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Information provided by: | Gloucester Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00379639 |
This is a phase I/II dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: Romidepsin (Depsipeptide)/Gemcitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors. |
Estimated Enrollment: | 40 |
Study Start Date: | July 2006 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Patients will receive 7,10, or 12 mg/m2 of romidepsin IV over 4 hours on either Days 1,8 and 15 or Days 1 and 15 of each 28-day cycle. Subsequent doses of romidepsin will based on treatment-related toxicities.
Patients will receive 600,800, 1000 or 1250 mg/m2 of gemcitabine infused (after completion of romidepsin infusion) over 30 minutes on either Days 1,8 and 15 (Schedule A) or Days 1 and 15 (Schedule B) of each 28 day cycle. Subsequent doses of gemcitabine will be based on treatment-related toxicities.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 |
Principal Investigator: | Howard A. Burris, M.D. | Sarah Cannon Research Institute |
Responsible Party: | Gloucester Pharmaceuticals, Inc. ( Jean Nichols, Ph.D. ) |
Study ID Numbers: | GPI-06-0003 |
Study First Received: | September 20, 2006 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00379639 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pancreatic cancer advanced solid tumors |
Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Romidepsin Antiviral Agents Immunosuppressive Agents |
Anti-Bacterial 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 Romidepsin Enzyme Inhibitors |
Antibiotics, Antineoplastic Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |