|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 3 |
| Study Start Date: | January 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gemcitabine + panitumumab
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: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00613730 History of Changes |
| Other Study ID Numbers: | 20060542 |
| Study First Received: | January 31, 2008 |
| Last Updated: | July 22, 2010 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma 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 Antibodies, Monoclonal |
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 |