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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00813605

Enrollment

155

Registered

2008-12-23

Start date

2009-03-31

Completion date

2012-06-30

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

AMG 655, AMG 479, Colon Cancer, Rectal Cancer, Monoclonal Antibody, Clinical Trial, Colorectal Cancer, metastatic colorectal cancer, metastatic cancer, antibody-2nd line, KRAS, adenocarcinoma

Brief summary

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

Interventions

OTHERFOLFIRI

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

BIOLOGICALAMG 655

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

OTHERPlacebo

Inactive dummy agent (to maintain blind)

BIOLOGICALAMG 479

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	Length of Study

Secondary

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

Countries

France, Hong Kong, Hungary, India, Italy, Poland, Russia, Singapore, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026