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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NantCell, Inc.
ClinicalTrials.gov Identifier:
NCT00813605
First received: December 22, 2008
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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

Condition Intervention Phase
Metastatic Colorectal Cancer
Other: FOLFIRI
Biological: AMG 655
Other: Placebo
Biological: AMG 479
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by NantCell, Inc.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Length of Study ]

Secondary Outcome Measures:
  • Overall Survival, Objective Response, Duration of Response, Time to Response [ Time Frame: Length of Study ]
  • Incidence of adverse events [ Time Frame: Length of Study ]
  • Significant laboratory abnormalities [ Time Frame: Length of Study ]
  • Incidence of antibody formation [ Time Frame: Length of Study ]

Enrollment: 155
Study Start Date: March 2009
Study Completion Date: June 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813605

  Show 67 Study Locations
Sponsors and Collaborators
NantCell, Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: NantCell, Inc.
ClinicalTrials.gov Identifier: NCT00813605     History of Changes
Other Study ID Numbers: 20060579
QUILT-2.018 ( Other Identifier: NantCell, Inc. )
Study First Received: December 22, 2008
Last Updated: October 26, 2016

Keywords provided by NantCell, Inc.:
AMG 655
AMG 479
Colon Cancer
Rectal Cancer
Monoclonal Antibody
Clinical Trial
Colorectal Cancer
metastatic colorectal cancer
metastatic cancer
antibody-2nd line
KRAS
adenocarcinoma

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2017