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

Primary Purpose

Adenocarcinoma of the Pancreas, Advanced Solid Tumors, Cancer

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AMG 479

Placebo

AMG 479

gemcitabine

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Pancreas focused on measuring pancreas, gemcitabine, metastatic, jaundice

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

AMG 479 12 mg/kg dose + gemcitabine

Placebo + gemcitabine

AMG 479 20 mg/kg + gemcitabine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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 Measures

Progression free survival

Objective response rate

Time to disease progression

Disease control rate

Number of subjects with adverse events

Full Information

NCT ID

NCT01231347

First Posted

October 14, 2010

Last Updated

October 26, 2016

Sponsor

NantCell, Inc.

Collaborators

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT01231347

Brief Title

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

Acronym

GAMMA

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Terminated

Why Stopped

Planned independent DMC Interim review: ended for futility w/no safety concerns

Study Start Date

April 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NantCell, Inc.

Collaborators

Takeda

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

pancreas, gemcitabine, metastatic, jaundice

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

800 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMG 479 12 mg/kg dose + gemcitabine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo + gemcitabine

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

AMG 479 20 mg/kg + gemcitabine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AMG 479

Intervention Description

AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo administered intravenously on days 1 and 15 of a 28 day cycle

Intervention Type

Drug

Intervention Name(s)

AMG 479

Intervention Description

AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle

Primary Outcome Measure Information:

Title

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

Time Frame