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

NantCell, Inc.155 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

155

Conditions

Metastatic Colorectal Cancer

Interventions

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

AMG 655BIOLOGICAL

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

PlaceboOTHER

Inactive dummy agent (to maintain blind)

AMG 479BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (67)

Research Site

Beverly Hills, California, United States

Research Site

Los Angeles, California, United States

Research Site

Santa Maria, California, United States

Research Site

Denver, Colorado, United States

Research Site

Denver, Colorado, United States

Research Site

Outcomes

Primary Outcomes

Progression Free Survival

Time frame: Length of Study

Secondary Outcomes

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

Data from ClinicalTrials.gov

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Miami, Florida, United States

Research Site

Ocala, Florida, United States

Research Site

Port Saint Lucie, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Chicago, Illinois, United States

...and 57 more locations