QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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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 / Treatment
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* Drug: AMG 479
* Drug: Placebo
* Drug: AMG 479
* Drug: gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AMG 479 12 mg/kg dose + gemcitabine<br>Arm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle | Drug: AMG 479<br>* AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle<br>Drug: gemcitabine<br>* gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle<br>* Other names: Gemzar;|
| Placebo Comparator: Placebo + gemcitabine<br>Arm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle | Drug: Placebo<br>* Placebo administered intravenously on days 1 and 15 of a 28 day cycle<br>Drug: gemcitabine<br>* gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle<br>* Other names: Gemzar;|
| Active Comparator: AMG 479 20 mg/kg + gemcitabine<br>Arm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle | Drug: AMG 479<br>* AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle<br>Drug: gemcitabine<br>* gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | After 825 subjects randomized + 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | After 825 subjects randomized + 24 months | 
| Objective response rate |  | After 825 subjects randomized + 24 months | 
| Time to disease progression |  | After 825 subjects randomized + 24 months | 
| Disease control rate |  | After 825 subjects randomized + 24 months | 
| Number of subjects with adverse events |  | After 825 subjects randomized + 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, pancreas, gemcitabine, jaundice