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

NantCell

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Biological: AMG 655; Other: Placebo; Biological: AMG 479; Other: FOLFIRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813605

20060579

QUILT-2.018 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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155 participants in 3 patient groups

Arm A

Experimental group

Description:

AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days

Treatment:

Other: Placebo

Other: FOLFIRI

Biological: AMG 655

Arm C

Active Comparator group

Description:

AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days

Treatment:

Other: Placebo

Other: FOLFIRI

Arm B

Experimental group

Description:

AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days

Treatment:

Biological: AMG 479

Other: Placebo

Other: FOLFIRI