QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma

October 26, 2016 updated by: NantCell, Inc.

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • France
      • Bordeaux Cedex, France, 33076
        • Research Site
      • Boulogne Billancourt, France, 92100
        • Research Site
      • Lille, France, 59020
        • Research Site
      • Lyon Cedex 08, France, 69373
        • Research Site
  • Hong Kong
      • New Territories, Hong Kong
        • Research Site
  • Hungary
      • Budapest, Hungary, 1097
        • Research Site
      • Gyor, Hungary, 9023
        • Research Site
      • Pecs, Hungary, 7624
        • Research Site
      • Szeged, Hungary, 6720
        • Research Site
  • India
      • Bangalore, India, 560 029
        • Research Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 082
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Research Site
      • Nagpur, Maharashtra, India, 440 012
        • Research Site
      • Nashik, Maharashtra, India, 422 005
        • Research Site
      • Pune, Maharashtra, India, 411 004
        • Research Site
    • West Bengal
      • Kolkata, West Bengal, India, 700 016
        • Research Site
  • Italy
      • Genova, Italy, 16132
        • Research Site
      • Milano, Italy, 20142
        • Research Site
      • Orbassano, Italy, 10043
        • Research Site
  • Poland
      • Gdansk, Poland, 80-952
        • Research Site
      • Gliwice, Poland, 44-101
        • Research Site
      • Opole, Poland, 45-060
        • Research Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Research Site
      • Kursk, Russian Federation, 305035
        • Research Site
      • Moscow, Russian Federation, 115478
        • Research Site
      • Obninsk, Russian Federation, 249036
        • Research Site
      • Saint Petersburg, Russian Federation, 191104
        • Research Site
      • Samara, Russian Federation, 443031
        • Research Site
      • St Petersburg, Russian Federation, 197089
        • Research Site
      • Ufa, Russian Federation, 450054
        • Research Site
  • Singapore
      • Singapore, Singapore, 169610
        • Research Site
      • Singapore, Singapore, 119228
        • Research Site
      • Singapore, Singapore, 308433
        • Research Site
  • Spain
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08035
        • Research Site
      • Barcelona, Cataluña, Spain, 08036
        • Research Site
      • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
        • Research Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Research Site
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Santa Maria, California, United States, 93454
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Research Site
      • Denver, Colorado, United States, 80220
        • Research Site
    • Florida
      • Miami, Florida, United States, 33136
        • Research Site
      • Ocala, Florida, United States, 34471
        • Research Site
      • Port Saint Lucie, Florida, United States, 34952
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
      • Joliet, Illinois, United States, 60435
        • Research Site
    • Indiana
      • Fishers, Indiana, United States, 46037
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Research Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Research Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Research Site
    • New York
      • Hudson, New York, United States, 12534
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19106
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Research Site
      • Austin, Texas, United States, 78731
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Temple, Texas, United States, 76508
        • Research Site
      • Tyler, Texas, United States, 75702
        • Research Site
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Research Site

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
  • Mutant-type KRAS tumor at screening
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
  • Adequate hematology, renal, hepatic, and coagulation function

Exclusion Criteria:

  • History or known presence of central nervous system metastases
  • History of other malignancy
  • Prior irinotecan-based chemotherapy for advanced/metastatic disease
  • Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
  • Uncontrolled cardiovascular disease

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
Other: FOLFIRI

Day 1 of each Cycle

Combination Therapy of:

irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion

Biological: AMG 655
AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
Other Names:
  • Conatumumab
Other: Placebo
Inactive dummy agent (to maintain blind)
Active Comparator: Arm C
AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
Other: FOLFIRI

Day 1 of each Cycle

Combination Therapy of:

irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion

Other: Placebo
Inactive dummy agent (to maintain blind)
Experimental: Arm B
AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
Other: FOLFIRI

Day 1 of each Cycle

Combination Therapy of:

irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion

Other: Placebo
Inactive dummy agent (to maintain blind)
Biological: AMG 479
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: Length of Study
Length of Study

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival, Objective Response, Duration of Response, Time to Response
Time Frame: Length of Study
Length of Study
Incidence of adverse events
Time Frame: Length of Study
Length of Study
Significant laboratory abnormalities
Time Frame: Length of Study
Length of Study
Incidence of antibody formation
Time Frame: Length of Study
Length of Study

Collaborators and Investigators

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

Sponsor

NantCell, Inc.

Publications and helpful links

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

Helpful Links

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 Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 22, 2008

First Submitted That Met QC Criteria

December 22, 2008

First Posted (Estimate)

December 23, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060579
  • QUILT-2.018 (Other Identifier: NantCell, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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