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| Sponsor: | Sarah Cannon Research Institute |
|---|---|
| Collaborator: |
Celgene Corporation |
| Information provided by: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00540579 |
Purpose
Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development as part of induction chemotherapy regimens for solid tumors. This study in pancreatic cancer is designed to determine the appropriate CC-4047 dose and regimen in combination with gemcitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreas |
Drug: CC-4047 and Gemcitabine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I/II Study of CC-4047 in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas |
| Estimated Enrollment: | 106 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Phase 1: Subjects will be enrolled in dose-escalating cohorts to be treated with CC-4047 on days 1-21 in combination with fixed doses of gemcitabine 1000 mg / m2 on days 1, 8, and 15 every 28 days.
Phase II: Subjects will be enrolled to receive oral CC-4047 at the MTD days 1 - 21 in combination with fixed doses of gemcitabine 1000 mg / m2 days 1, 8, and 15 every 28 days.
Phase I
Primary:
• To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral CC-4047 given on days 1-21 in combination with gemcitabine on days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.
Secondary:
• To explore the anti-tumor activity of the combination of CC-4047 and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.
Phase II
Primary:
• To explore the anti-tumor activity of the combination of CC-4047 on days 1-21 and gemcitabine on days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.
Secondary:
• To evaluate the safety profile of the combination of CC-4047 and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following laboratory abnormalities:
Surgery or radiation therapy within 14 days of study enrollment as outlined below.
Contacts and Locations| United States, Colorado | |
| University of Colorado Cancer Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Tennessee | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
| Study Chair: | Jeffrey Infante, M.D. | Sarah Cannon Research Institute |
More Information
| Responsible Party: | SCRI Oncology Research Consortium ( Jeffrey Infante, M.D. ) |
| Study ID Numbers: | SCRI GI 105, PO-PANC-PI-009 |
| Study First Received: | October 5, 2007 |
| Last Updated: | June 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00540579 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pancreas Untreated Advanced Gemcitabine CC-4047 |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Gastrointestinal Agents Endocrine System Diseases Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pancrelipase Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |