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Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adenocarcinoma of the Pancreas; Advanced Solid Tumors; Cancer; Cancer of Pancreas; Cancer of the Pancreas; Metastases; Metastatic Cancer; Metastatic Pancreatic Cancer; Pancreas Cancer; Pancreatic Cancer; Bone Metastases; Endocrine Cancer; Oncology; Oncology Patients; Solid Tumors; Advanced Malignancy

Intervention: AMG 479 (Drug); Placebo (Drug); AMG 479 (Drug); gemcitabine (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

Clinical Details

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas

Secondary outcome:

Progression free survival

Objective response rate

Time to disease progression

Disease control rate

Number of subjects with adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Untreated metastatic adenocarcinoma of the pancreas

- Adequate hematologic, renal and liver function

- Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

- Prior chemotherapy or radiotherapy for pancreatic cancer

- Central nervous system metastases

- External biliary drain

Locations and Contacts

Research Site, Innsbruck 6020, Austria

Research Site, Salzburg 5020, Austria

Research Site, Steyr 4400, Austria

Research Site, Wien 1090, Austria

Research Site, Bruxelles 1070, Belgium

Research Site, Charleroi 6000, Belgium

Research Site, Edegem 2650, Belgium

Research Site, Gent 9000, Belgium

Research Site, Leuven 3000, Belgium

Research Site, Libramont 6800, Belgium

Research Site, São Paulo 01246-000, Brazil

Research Site, Sofia 1527, Bulgaria

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Research Site, Varna 9010, Bulgaria

Research Site, Quebec G1R 2J6, Canada

Research Site, Brno 656 53, Czech Republic

Research Site, Brno 656 91, Czech Republic

Research Site, Hradec Kralove 500 05, Czech Republic

Research Site, Olomouc 775 20, Czech Republic

Research Site, Praha 2 128 08, Czech Republic

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Research Site, Aalborg 9000, Denmark

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Research Site, Odense 5000, Denmark

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Research Site, Brest cedex 29609, France

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Research Site, Berlin 13353, Germany

Research Site, Dresden 01307, Germany

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Additional Information

AmgenTrials clinical trials website

Related publications:

Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Świeboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-7. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.

Starting date: April 2011
Last updated: March 28, 2014

Page last updated: August 23, 2015

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