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

Phase 3

Completed

• Conditions: Adenocarcinoma of the Pancreas; Advanced Solid Tumors; Cancer; Cancer of Pancreas; Metastatic Pancreatic Cancer; Pancreas Cancer; Cancer of the Pancreas; Metastases; Metastatic Cancer; Pancreatic Cancer
• Interventions: Drug: Placebo; Drug: AMG 479; Drug: gemcitabine

• Registration Number: NCT01231347
• Lead Sponsor: NantCell, Inc.

Brief 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. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-11-01
• Study Start: 2011-04-07
• Primary Completion: 2012-12-12
• Study Completion: 2012-12-12
• Disposition First Submitted: 2014-02-21
• Disposition First Submitted QC: 2014-03-28
• Disposition First Posted: 2014-04-25
• Results First Submitted: 2024-04-17
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Results First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + gemcitabine	Placebo	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
AMG 479 12 mg/kg dose + gemcitabine	AMG 479	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
AMG 479 20 mg/kg + gemcitabine	AMG 479	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
AMG 479 20 mg/kg + gemcitabine	gemcitabine	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
Placebo + gemcitabine	gemcitabine	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
AMG 479 12 mg/kg dose + gemcitabine	gemcitabine	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

Primary Outcome Measures

Name	Time	Method
Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas	From randomization up to 20 months	The primary endpoint of the study was OS, defined as the time from randomization to death.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Northampton, United Kingdom