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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00613730 |
Purpose
This is a phase II, multi-center, open-label, single-arm clinical trial to be conducted in the United States. In approximately 55 centers, approximately 75 eligible locally advanced unresectable or metastatic pancreatic cancer subjects will be enrolled to receive first-line therapy of gemcitabine and panitumumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer of Pancreas Cancer of the Pancreas Pancreas Cancer Pancreatic Cancer |
Drug: Gemcitabine Drug: panitumumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II, Multi-center, Open-label, Single-Arm Study Using Gemcitabine and Panitumumab in the First-line Treatment of Subjects With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas |
| Estimated Enrollment: | 75 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | August 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Gemcitabine + panitumumab: Experimental
SIngle Arm Trial
|
Drug: Gemcitabine
Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 over 30 minutes, on day 1, once weekly for 7 weeks followed by a 1 week rest. Subsequent cycles consist of injections, on day 1, once weekly for 3 consecutive weeks out of every 4 weeks.
Drug: panitumumab
Panitumumab 6 mg/kg will be infused, intravenously, over 1 hour ± 15 minutes on day 1 of weeks 1, 3, 5, 7, and Q2W on days 1 and 15 of each subsequent chemotherapy cycle, immediately, before starting chemotherapy.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Research Site | |
| Boynton Beach, Florida, United States | |
| United States, Kentucky | |
| Research Site | |
| Paducah, Kentucky, United States | |
| United States, Maryland | |
| Research Site | |
| Clinton, Maryland, United States | |
| Study Director: | MD | Amgen |
More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20060542 |
| Study First Received: | January 31, 2008 |
| Last Updated: | August 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00613730 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
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 |
Neoplasms by Histologic Type Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |