QUILT-2.014: Gemcitabine And AMG 479 In Metastatic Adenocarcinoma Of The Pancreas

Study Overview

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

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.

N/A

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

DRUG: AMG 479
DRUG: Placebo
DRUG: AMG 479
DRUG: gemcitabine

20060540
GAMMA
QUILT-2.014 (OTHER Identifier) (OTHER: NantCell, Inc.)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-10-14	Results First Submitted 2024-04-17	Last Update Submitted that met QC Criteria 2024-06-24
First Submitted that Met QC Criteria 2010-10-28	Results First Submitted that Met QC Criteria 2024-06-24	Last Update Posted (ACTUAL) 2024-07-16
First Posted (ACTUAL) 2010-11-01	Results First Posted 2024-07-16	Last Verified 2024-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
PLACEBO_COMPARATOR: Placebo + 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	DRUG: Placebo Placebo administered intravenously on days 1 and 15 of a 28 day cycle DRUG: gemcitabine gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
EXPERIMENTAL: AMG 479 12 mg/kg dose + 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	DRUG: AMG 479 AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle DRUG: gemcitabine gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
EXPERIMENTAL: AMG 479 20 mg/kg + 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	DRUG: AMG 479 AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle DRUG: gemcitabine gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle

Participant Group/Arm

Intervention/Treatment

PLACEBO_COMPARATOR: Placebo + 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

DRUG: Placebo

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

DRUG: gemcitabine

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

EXPERIMENTAL: AMG 479 12 mg/kg dose + 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

DRUG: AMG 479

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

DRUG: gemcitabine

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

EXPERIMENTAL: AMG 479 20 mg/kg + 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

DRUG: AMG 479

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

DRUG: gemcitabine

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

Primary Outcome Measures	Measure Description	Time Frame
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	The primary endpoint of the study was OS, defined as the time from randomization to death.	From randomization up to 20 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Untreated metastatic adenocarcinoma of the pancreas
Adequate hematologic, renal and liver function
Eastern Cooperative Oncology Group (ECOG) 0 or 1

Prior chemotherapy or radiotherapy for pancreatic cancer
Central nervous system metastases
External biliary drain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Takeda

Investigators

PRINCIPAL_INVESTIGATOR: NantKWest Clinical Review Team, ImmunityBio, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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, Swieboda-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):921-927. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.

Learn

Resources

Patients

Caregivers

Clinical Trial Record