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Completed

NCT Number: NCT00813605

QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in 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

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Key information

Conditions

Metastatic Colorectal Cancer Adenocarcinoma Carcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOLFIRI

Other

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

AMG 655

Biological

AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)

Other names: Conatumumab

Placebo

Other

Inactive dummy agent (to maintain blind)

AMG 479

Biological

AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1

Primary outcomes

  1. Progression Free Survival

    Time frame: Length of Study

Secondary outcomes

  1. Overall Survival, Objective Response, Duration of Response, Time to Response

    Time frame: Length of Study

  2. Incidence of adverse events

    Time frame: Length of Study

  3. Significant laboratory abnormalities

    Time frame: Length of Study

  4. Incidence of antibody formation

    Time frame: Length of Study

Sponsors and collaborators

Lead sponsor

NantCell, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 23, 2008
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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