QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer
NCT ID: NCT00630552
Last Updated: 2024-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
138 participants
INTERVENTIONAL
2007-06-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655
AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655
AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655
AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479
AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo
Inactive dummy of AMG 655.
Interventions
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Placebo
Inactive dummy of AMG 655.
AMG 479
AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
AMG 655
AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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NantCell, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Alhambra, California, United States
Research Site
Bakersfield, California, United States
Research Site
Fullerton, California, United States
Research Site
La Jolla, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Northridge, California, United States
Research Site
Oxnard, California, United States
Research Site
Rancho Mirage, California, United States
Research Site
Redondo Beach, California, United States
Research Site
San Francisco, California, United States
Research Site
Santa Maria, California, United States
Research Site
Santa Monica, California, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Marietta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Harvey, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Westminster, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Henderson, Nevada, United States
Research Site
Albany, New York, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Hickory, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Eugene, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Providence, Rhode Island, United States
Research Site
Greenville, South Carolina, United States
Research Site
Austin, Texas, United States
Research Site
Austin, Texas, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Round Rock, Texas, United States
Research Site
Tyler, Texas, United States
Research Site
Tacoma, Washington, United States
Research Site
Yakima, Washington, United States
Countries
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References
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Cella D, Butt Z, Kindler HL, Fuchs CS, Bray S, Barlev A, Oglesby A. Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer. Qual Life Res. 2013 Jun;22(5):1105-12. doi: 10.1007/s11136-012-0217-4. Epub 2012 Jun 8.
Kindler HL, Richards DA, Garbo LE, Garon EB, Stephenson JJ Jr, Rocha-Lima CM, Safran H, Chan D, Kocs DM, Galimi F, McGreivy J, Bray SL, Hei Y, Feigal EG, Loh E, Fuchs CS. A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer. Ann Oncol. 2012 Nov;23(11):2834-2842. doi: 10.1093/annonc/mds142. Epub 2012 Jun 13.
Lu, JF.Exposure-response analysis to facilitate phase 3 dose selection for Ganitumumab (AMG 479) in combination with Gemcitabine to treat metastatic pancreatic cancer.Journal-000728;
McCaffery I, Tudor Y, Deng H, Tang R, Suzuki S, Badola S, Kindler HL, Fuchs CS, Loh E, Patterson SD, Chen L, Gansert JL. Putative predictive biomarkers of survival in patients with metastatic pancreatic adenocarcinoma treated with gemcitabine and ganitumab, an IGF1R inhibitor. Clin Cancer Res. 2013 Aug 1;19(15):4282-9. doi: 10.1158/1078-0432.CCR-12-1840. Epub 2013 Jun 5.
TBD.Validation of the FACT-hepatobiliary questionnaire in metastatic pancreatic cancer population.Journal-004521;
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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QUILT-2.019
Identifier Type: OTHER
Identifier Source: secondary_id
20060323
Identifier Type: -
Identifier Source: org_study_id
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