Clinical trial NCT00813605: QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: NantCell, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Length of Study
Secondary outcomes:
measure: Overall Survival, Objective Response, Duration of Response, Time to Response
timeFrame: Length of Study
measure: Incidence of adverse events
timeFrame: Length of Study
measure: Significant laboratory abnormalities
timeFrame: Length of Study
measure: Incidence of antibody formation
timeFrame: Length of Study
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Santa Maria
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Miami
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Port Saint Lucie
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Joliet
country: United States
facility: Research Site
state: Illinois
city: Fishers
country: United States
facility: Research Site
state: Indiana
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Lebanon
country: United States
facility: Research Site
state: New Hampshire
city: Hudson
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Amarillo
country: United States
facility: Research Site
state: Texas
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Temple
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Roanoke
country: United States
facility: Research Site
state: Virginia
city: Bordeaux Cedex
country: France
facility: Research Site
city: Boulogne Billancourt
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Lyon Cedex 08
country: France
facility: Research Site
city: New Territories
country: Hong Kong
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Nagpur
country: India
facility: Research Site
state: Maharashtra
city: Nashik
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Bangalore
country: India
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Gliwice
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Kursk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
state: CataluÃ±a
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: