A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer

NCT01767857 | Terminated Phase 3 Results DMC

• 1 other identifier: 2012-PT023
• Study Type: interventional
• Target: 643
• Locations: 12 countries
• Sites: 108

Brief Summary

The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.

Conditions

Metastatic Colorectal Cancer

Keywords

Pivotal; Colorectal; Survival; Phase 3

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival time was defined as the duration from the date of randomization until death or last follow-up. OS was summarized by Kaplan-Meier method and compared between the treatment groups using un-adjusted log-rank test.

  Up to 18 months

Secondary Outcomes (6)

• Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans

  Baseline and Week 8

• Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)

  Baseline and Week 8

• Change From Baseline in Platelet Counts

  Baseline and Week 8

• Progression Free Survival (PFS)

  Up to 18 Months

• Percentage of Participants With Objective Response (OR)

  Up to 18 months

Study Arms (2)

Xilonix

EXPERIMENTAL

MABp1 administered IV every two weeks, plus best supportive care

Drug: Xilonix

Placebo

PLACEBO COMPARATOR

Placebo administered IV every two weeks, plus best supportive care

Drug: Placebo

Interventions

Xilonix DRUG

Xilonix is a True Human Monoclonal Antibody targeting Interleukin 1 alpha, and is administered intravenously every 2 weeks with best supportive care until clinical or radiographic progression.

Also known as: MABp1, CA-18C3

Xilonix

Placebo DRUG

Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have experienced progression (or intolerance) after treatment with standard approved regimens including, oxaliplatin, irinotecan flouropyrimidine, bevacizumab, and cetuximab or panitumumab if KRAS wildtype.
• Subjects will not be treated with any radiation, chemotherapy, or investigational agents while enrolled in this protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.
• At least 2 weeks since the last previous cancer treatment including: chemotherapy, radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics.
• Age ≥ 18 years, male or female subjects.
• Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal.
• Adequate renal function, defined by serum creatinine ≤ 1.5 x ULN.
• Adequate hepatic function
• Adequate bone marrow function
• For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
• Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed.
• Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on the clinical trial for three months.

You may not qualify if:

• Mechanical obstruction that would prevent adequate oral nutritional intake.
• Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
• Uncontrolled or significant cardiovascular disease, including:
• Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
• Subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1; excluding alopecia and grade 2 neuropathy.
• Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV).
• Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of hepatitis C RNA.
• History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).
• Receipt of a live (attenuated) vaccine within 1 month prior to Screening
• Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition of XILONIX™.
• Women who are pregnant or breastfeeding.
• WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication.
• Weight loss \>20% in the previous 6 months.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (113)

Alabama Oncology, Bruno Cancer Center

Birmingham, Alabama, 35205, United States

Location

Southern Cancer Center, PC

Mobile, Alabama, 36608, United States

Location

Northwest Alabama Cancer Center, PC

Muscle Shoals, Alabama, 35661, United States

Location

Arizona Oncology Associates

Tucson, Arizona, United States

Location

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

California Cancer Associates for Research and Excellence, Inc. (cCARE)

Fresno, California, 93720, United States

Location

St. Jude Medical Center

Fullerton, California, 92835, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, United States

Location

USC Norris Comprehensive Cancer Center and LAC USC Medical Center

Los Angeles, California, United States

Location

Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

American Institute of Research

Whittier, California, 90603, United States

Location

Advanced Medical Specialists

Miami, Florida, United States

Location

Lewis Hall Singletary Oncology Center

Thomasville, Georgia, 31792, United States

Location

Swedish Covenant Hospital via Clintell, Inc.

Chicago, Illinois, 60625, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Hines VA Hospital

Hines, Illinois, 60141, United States

Location

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

Hutchinson Clinic, P.A.

Hutchinson, Kansas, 67502, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

The Center for Cancer and Blood Disorders, a Division of Regional Cancer Care Associates LLC.

Bethesda, Maryland, 20817, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Park Nicollet

Minneapolis, Minnesota, 55416, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

North Shore Hematology Oncology Associates, PC

East Setauket, New York, 11733, United States

Location

Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

East Carolina Health - Beaufort, Inc. DBA Marion L. Shepard Cancer Center

Washington, North Carolina, 27889, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, United States

Location

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

Location

St. Charles Health System, Inc.

Bend, Oregon, 97701, United States

Location

Good Samaritan Hospital Corvallis - SHOC

Corvallis, Oregon, 97330, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

Charleston Hematology Oncology Associates, PA

Charleston, South Carolina, 29414, United States

Location

Bon Secours Saint Francis Cancer Center

Greenville, South Carolina, 29651, United States

Location

Texas Oncology

Bedford, Texas, 76022, United States

Location

Coastal Bend Cancer Center

Corpus Christi, Texas, 78404, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75230, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - Dallas

Dallas, Texas, United States

Location

Texas Oncology - Grapevine

Grapevine, Texas, 76051, United States

Location

Millennium Oncology

Houston, Texas, 77090, United States

Location

Methodist Richardson Cancer Center

Richardson, Texas, 75802, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Scott & White Healthcare

Temple, Texas, 76508, United States

Location

Texas Oncology - Longview and Tyler

Tyler, Texas, United States

Location

University of TX Health Science Center at Tyler

Tyler, Texas, United States

Location

Virginia Oncology Associates

Multiple Locations, Virginia, United States

Location

Providence Regional Medical Center Everett, PRCP - Clinical Research

Everett, Washington, 98201, United States

Location

SCCA - Evergreen Health

Kirkland, Washington, 98034, United States

Location

University of Washington

Multiple Locations, Washington, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

SCCA - Group Health

Seattle, Washington, 98112, United States

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4029, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Western Health - Sunshine Hospital

Saint Albans, Victoria, 3021, Australia

Location

Hospital Barmherzige Schwestern Linz

Linz, 4010, Austria

Location

Krankenhaus der Barmherzigen Schwestern Linz

Linz, 4010, Austria

Location

LKH Salzburg 3rd Medical Department with Hematology

Salzburg, 5020, Austria

Location

Klinikum Wels-Grieskirchen GmbH, IV. Internal Department

Wels, 4600, Austria

Location

Grand Hôpital de Charleroi, Grand Rue 3

Charleroi, Hainaut, 6000, Belgium

Location

CHU Dinant Godinne UCL Namur

Yvoir, Namur, 5530, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Antwerp University Hospital

Edegem, 2650, Belgium

Location

Domaine Universitaire du Sart Tilman

Liège, 4000, Belgium

Location

Masarykův onkologický ústav

Brno, 65653, Czechia

Location

Všeobecné fakultní nemocnice v Praze, Onkologická klinika

Prague, 12808, Czechia

Location

Thomayerova nemocnice, Onkologická klinika 1.LF TN Praha

Prague, 14059, Czechia

Location

Fakultní nemocnice v Motole, Komplexní onkologické centrum

Prague, 15006, Czechia

Location

Semmelweis University 1st Dept. Of Internal Medicine, Oncology Division

Budapest, 1083, Hungary

Location

"B" Dept. Of Internal Medicine, National Institute of Oncology

Budapest, 1122, Hungary

Location

Uzsoki Hospital, Dept. of Oncoradiology

Budapest, 1145, Hungary

Location

Dept. Of Oncology, Somogy County Kaposi Mor Teaching Hospital

Kaposvár, 7400, Hungary

Location

Dept. Of Oncology, Tolna County Balassa Janos Hospital

Szekszárd, 7100, Hungary

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

FONDAZIONE POLIAMBULANZA â€" ISTITUTO OSPEDALIERO

Brescia, 25124, Italy

Location

A.O. Universitaria Arcispedale S.Anna Di Ferrara

Cona, 44124, Italy

Location

Azienda Ospedaliera University Pisana Uo Oncol Medica 2

Pisa, 56126, Italy

Location

U.O. Oncologia Medica

Pontedera, 56025, Italy

Location

San Giovanni Calibita" Fatebenefratelli Hospital

Rome, 186, Italy

Location

Academic Medical Centre Amsterdam

Amsterdam, 1105AZ, Netherlands

Location

Amphia Hospital

Breda, 4819EV, Netherlands

Location

University Medical Center Utrecht Heidelberglaan

Utrecht, 3584CX, Netherlands

Location

Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku Odzial Onkologii Klinicznej

Bialystok, 15027, Poland

Location

Regionalne Centrum Onkologii Szpitala im. Prof. Franciszka Łukaszczyka

Bydgoszcz, 85796, Poland

Location

Szpital Wojewodzki w Gdyni Sp. Z o.o., Szpital Morski im PCK

Gdynia, 81519, Poland

Location

Przychodnia Lekarska "Komed"

Konin, 62500, Poland

Location

NZOZ Vesalius

Krakow, 31108, Poland

Location

Samodzielny Publiczny ZOZ MSZ z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, 10228, Poland

Location

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej

Warsaw, 02781, Poland

Location

NZOZ Magodent sp z.o.o.

Warsaw, 04125, Poland

Location

Instituto Oncológico Dr. Rosell.

Barcelona, 8028, Spain

Location

Hospital Vall Dhebron Edificio Principal Planta Baja

Barcelona, 8035, Spain

Location

Institut Català d'Oncologia, Hospital Duran i Reynals

Barcelona, 8907, Spain

Location

Institut Català d'Oncologia

Barcelona, 8916, Spain

Location

Hospital ClÃ-nica Benidorm

Benidorm, 3501, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital 12 De Octubre

Madrid, 28041, Spain

Location

CIOCC, Centro Integral Oncológico Clara Campal

Madrid, 28050, Spain

Location

Hospital Son Llà tzer

Palma, 7198, Spain

Location

Hospital Universitario La Fe, Consultas Externas Oncologia

Valencia, 46026, Spain

Location

Istituto Oncologico della Svizzera Italiania

Bellinzona, 6500, Switzerland

Location

Kantonsspital GraubÃnden

Chur, 7000, Switzerland

Location

Christie Hospital

Manchester, Greater Manchester, United Kingdom

Location

The Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Location

Related Publications (1)

• Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. MABp1, a first-in-class true human antibody targeting interleukin-1alpha in refractory cancers: an open-label, phase 1 dose-escalation and expansion study. Lancet Oncol. 2014 May;15(6):656-66. doi: 10.1016/S1470-2045(14)70155-X. Epub 2014 Apr 17.

  PMID: 24746841 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

bermekimab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Product Development Portfolio Leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 14, 2013
• Study Start: March 31, 2013
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: June 29, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Locations

ES (10); HU (5); CH (2); IL (2); US (57); BE (6); AU (4); IT (5); NL (3); PL (8); GB (2); CZ (4)