|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | January 2011 |
| 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: | Jeffrey Infante, M.D., SCRI Oncology Research Consortium |
| ClinicalTrials.gov Identifier: | NCT00540579 History of Changes |
| Other Study ID Numbers: | SCRI GI 105, PO-PANC-PI-009 |
| Study First Received: | October 5, 2007 |
| Last Updated: | May 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Pancreas Untreated Advanced Gemcitabine CC-4047 |
|
Carcinoma Pancreatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Pancrelipase Gemcitabine Gastrointestinal Agents |
Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |