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QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00630552
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
NantCell, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Adenocarcinoma of the Pancreas Metastatic Pancreatic Cancer Pancreatic Cancer Other: Placebo Drug: AMG 479 Drug: AMG 655 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : June 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Survival [ Time Frame: 6 months ]
  2. Safety [ Time Frame: Length of the study ]

Secondary Outcome Measures :
  1. Safety and Efficacy Endpoints [ Time Frame: Length of the study ]
  2. Overall Survival [ Time Frame: Length of the study ]
  3. Time to Response [ Time Frame: Length of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630552


Locations
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United States, California
Research Site
Alhambra, California, United States, 91801
Research Site
Bakersfield, California, United States, 93309
Research Site
Fullerton, California, United States, 92835
Research Site
La Jolla, California, United States, 92093
Research Site
Long Beach, California, United States, 90813
Research Site
Los Angeles, California, United States, 90095
Research Site
Northridge, California, United States, 91328
Research Site
Oxnard, California, United States, 93030
Research Site
Rancho Mirage, California, United States, 92270
Research Site
Redondo Beach, California, United States, 90277
Research Site
San Francisco, California, United States, 94115
Research Site
Santa Maria, California, United States, 93454
Research Site
Santa Monica, California, United States, 90403
United States, Florida
Research Site
Miami, Florida, United States, 33136
Research Site
Orlando, Florida, United States, 32804
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30309
Research Site
Atlanta, Georgia, United States, 30341
Research Site
Marietta, Georgia, United States, 30060
United States, Illinois
Research Site
Chicago, Illinois, United States, 60637
Research Site
Harvey, Illinois, United States, 60426
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21204
Research Site
Westminster, Maryland, United States, 21157
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
Research Site
Boston, Massachusetts, United States, 02115
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63141
United States, Nevada
Research Site
Henderson, Nevada, United States, 89052
United States, New York
Research Site
Albany, New York, United States, 12206
Research Site
New York, New York, United States, 10016
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
Research Site
Hickory, North Carolina, United States, 28602
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
United States, Oregon
Research Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19106
Research Site
Pittsburgh, Pennsylvania, United States, 15261
United States, Rhode Island
Research Site
Providence, Rhode Island, United States, 02903
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29615
United States, Texas
Research Site
Austin, Texas, United States, 78705
Research Site
Austin, Texas, United States, 78731
Research Site
Austin, Texas, United States, 78745
Research Site
Dallas, Texas, United States, 75246
Research Site
Round Rock, Texas, United States, 78681
Research Site
Tyler, Texas, United States, 75702
United States, Washington
Research Site
Tacoma, Washington, United States, 98405
Research Site
Yakima, Washington, United States, 98902
Sponsors and Collaborators
NantCell, Inc.
Investigators
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Study Director: MD Amgen
Additional Information:
Publications:
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Responsible Party: NantCell, Inc.
ClinicalTrials.gov Identifier: NCT00630552    
Other Study ID Numbers: 20060323
QUILT-2.019 ( Other Identifier: NantCell, Inc. )
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Keywords provided by NantCell, Inc.:
AMG 479
Gemcitabine
TR-2
IGF-1R
AMG 655
Pancreatic cancer
Adenocarcinoma of the Pancreas
Metastatic Pancreatic Cancer
Additional relevant MeSH terms:
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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
Conatumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents