A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00630552
First received: February 28, 2008
Last updated: October 29, 2012
Last verified: October 2012
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Purpose
This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Pancreas Metastatic Pancreatic Cancer Pancreatic Cancer |
Other: Placebo Drug: AMG 479 Drug: AMG 655 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety [ Time Frame: Length of the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and Efficacy Endpoints [ Time Frame: Length of the study ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Length of the study ] [ Designated as safety issue: No ]
- Time to Response [ Time Frame: Length of the study ] [ Designated as safety issue: No ]
| Enrollment: | 138 |
| Study Start Date: | June 2007 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo + Gemcitabine |
Other: Placebo
Inactive dummy of AMG 655.
|
| Experimental: AMG 655 + Gemcitabine |
Drug: AMG 655
AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|
| Experimental: AMG 479 + Gemcitabine |
Drug: AMG 479
AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV)
- Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery.
Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
- Men or women ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Adequate hematologic, hepatic, renal and coagulation function
- Amylase and lipase ≤ 2.0 x ULN
- Adequately controlled type 1 or 2 diabetic subjects
Exclusion Criteria:
- Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma
- Known central nervous system metastases
- Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity
- Adjuvant chemotherapy or chemoradiotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630552
Show 44 Study Locations
Show 44 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00630552 History of Changes |
| Other Study ID Numbers: | 20060323 |
| Study First Received: | February 28, 2008 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board United States: Western Institutional Review Board |
Keywords provided by Amgen:
|
AMG 479 Gemcitabine TR-2 IGF-1R |
AMG 655 Pancreatic cancer Adenocarcinoma of the Pancreas Metastatic Pancreatic Cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013