Clinical Trials Logo
  1. Home
  2. Metastatic Colorectal Cancer
  3. NCT00813605
  4. Details
NCT00813605 Clinical Trial

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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00813605
Other study ID # 20060579
Secondary ID QUILT-2.018
Status Completed
Phase Phase 2
First received December 22, 2008
Last updated October 26, 2016
Start date March 2009
Est. completion date June 2012

Study information
Verified date October 2016
Source NantCell, Inc.
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: CCPPRB Central Ethics CommitteeFrance: Central Ethic CommitteeHong Kong: Department of HealthRussia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health)Hungary: National Institute of PharmacyIndia: Central Drugs Standard Control OrganizationIndia: Indian Council of Medical ResearchItaly: Ethics CommitteePoland: Drug InstitutPoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ethics CommitteeRussia: FSI National Center of Expertise of Medicinal ProductsRussia: Ministry of Health of the Russian FederationSingapore: Health Science AuthoritySpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comite Etico de Investigacion ClinicaSpain: Comité ético del Hospital Vall d'HebronSpain: Spanish Drug AgencyUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Western Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date June 2012
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• 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
Biological:
• AMG 655
AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
Other:
• Placebo
Inactive dummy agent (to maintain blind)
Biological:
• AMG 479
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1

Locations
Country Name City State
France Research Site Bordeaux Cedex
France Research Site Boulogne Billancourt
France Research Site Lille
France Research Site Lyon Cedex 08
Hong Kong Research Site New Territories
Hungary Research Site Budapest
Hungary Research Site Gyor
Hungary Research Site Pecs
Hungary Research Site Szeged
India Research Site Bangalore
India Research Site Hyderabad Andhra Pradesh
India Research Site Kolkata West Bengal
India Research Site Mumbai Maharashtra
India Research Site Nagpur Maharashtra
India Research Site Nashik Maharashtra
India Research Site Pune Maharashtra
Italy Research Site Genova
Italy Research Site Milano
Italy Research Site Orbassano
Poland Research Site Gdansk
Poland Research Site Gliwice
Poland Research Site Opole
Russian Federation Research Site Arkhangelsk
Russian Federation Research Site Kursk
Russian Federation Research Site Moscow
Russian Federation Research Site Obninsk
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Samara
Russian Federation Research Site St Petersburg
Russian Federation Research Site Ufa
Singapore Research Site Singapore
Singapore Research Site Singapore
Singapore Research Site Singapore
Spain Research Site Barcelona Cataluña
Spain Research Site Barcelona Cataluña
Spain Research Site L'Hospitalet de Llobregat Cataluña
Spain Research Site Madrid
Spain Research Site Madrid
Spain Research Site Pamplona Navarra
United States Research Site Amarillo Texas
United States Research Site Atlanta Georgia
United States Research Site Austin Texas
United States Research Site Beverly Hills California
United States Research Site Chicago Illinois
United States Research Site Columbus Ohio
United States Research Site Dallas Texas
United States Research Site Denver Colorado
United States Research Site Denver Colorado
United States Research Site Fishers Indiana
United States Research Site High Point North Carolina
United States Research Site Hudson New York
United States Research Site Joliet Illinois
United States Research Site Lebanon New Hampshire
United States Research Site Los Angeles California
United States Research Site Miami Florida
United States Research Site New York New York
United States Research Site Ocala Florida
United States Research Site Paducah Kentucky
United States Research Site Philadelphia Pennsylvania
United States Research Site Philadelphia Pennsylvania
United States Research Site Port Saint Lucie Florida
United States Research Site Roanoke Virginia
United States Research Site Santa Maria California
United States Research Site Temple Texas
United States Research Site Tyler Texas
United States Research Site Wichita Kansas
United States Research Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
NantCell, Inc.

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free Survival Length of Study No
Secondary Overall Survival, Objective Response, Duration of Response, Time to Response Length of Study No
Secondary Incidence of adverse events Length of Study Yes
Secondary Significant laboratory abnormalities Length of Study Yes
Secondary Incidence of antibody formation Length of Study Yes
See also
  Status Clinical Trial Phase
Completed NCT01228734 - A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients Phase 3
Completed NCT05178745 - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Completed NCT01591421 - P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer. Phase 1/Phase 2
Withdrawn NCT05412706 - Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy Phase 2
Withdrawn NCT04430985 - FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer Phase 2
Withdrawn NCT03182894 - Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT05725200 - Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer Phase 2
Terminated NCT03176264 - PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer Phase 1
Completed NCT04866290 - HepaSphere™ Microspheres Prospective Registry
Not yet recruiting NCT06425133 - Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers Phase 2
Not yet recruiting NCT05531045 - 18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Completed NCT02906059 - Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer Phase 1
Active, not recruiting NCT02575378 - Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer Phase 4
Withdrawn NCT02535988 - Abscopal Effect for Metastatic Colorectal Cancer Phase 2
Recruiting NCT02848807 - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life N/A
Active, not recruiting NCT02077868 - Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment Phase 3
Completed NCT02414009 - Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients Phase 2
Active, not recruiting NCT01949194 - Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers Phase 2
Withdrawn NCT01915472 - A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer Phase 2

External Links