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

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Other: FOLFIRI; Other: Placebo; Biological: AMG 655; Biological: AMG 479

• Registration Number: NCT00813605
• Lead Sponsor: NantCell, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-22
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Study Start: 2009-03
• Primary Completion: 2011-01
• Study Completion: 2012-06
• Disposition First Submitted: 2016-03-07
• Disposition First Submitted QC: 2016-03-07
• Disposition First Posted: 2016-04-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C	Placebo	AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
Arm A	FOLFIRI	AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
Arm C	FOLFIRI	AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
Arm B	FOLFIRI	AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
Arm B	Placebo	AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
Arm A	AMG 655	AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
Arm A	Placebo	AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
Arm B	AMG 479	AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Length of Study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain