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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

NantCell, Inc.

Study Description

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

Study Design

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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

MedlinePlus related topics: Pancreatic Cancer

Drug Information available for: Gemcitabine

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

U.S. FDA Resources

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

Survival [ Time Frame: 6 months ]
Safety [ Time Frame: Length of the study ]

Secondary Outcome Measures :

Safety and Efficacy Endpoints [ Time Frame: Length of the study ]
Overall Survival [ Time Frame: Length of the study ]
Time to Response [ Time Frame: Length of the study ]

Eligibility Criteria

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

Contacts and Locations

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

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

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;

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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

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