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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01767857
Recruitment Status : Terminated (The study crossed the prospective futility boundary of primary endpoint)
First Posted : January 14, 2013
Last Update Posted : October 19, 2020
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Xilonix Drug: Placebo Phase 3

Detailed Description:

In the setting of refractory, metastatic disease a complete resolution of tumor burden is not a reasonable expectation. Instead, the primary goal of anti-tumor therapy at this stage is to eliminate or reduce the symptomatic effects of the tumor, while trying to prolong survival for as long as possible. Due to treatment related morbidity however, few treatment modalities are ideal for this objective. Even with the most recent targeted agents (such as multi-kinase inhibitors), drug related toxicities frequently lead to relatively short treatment durations. With discontinuation of therapy, disease progression is uncontrolled and prognosis is poor.

New agents that control disease progression-while improving tumor-related symptoms, rather than causing significant therapy related morbidity-are vitally needed to treat patients with advanced cancer, including those with colorectal cancer. An approach has been taken to develop such an agent using a monoclonal antibody to block the chronic inflammation involved in both malignant disease progression and constitutional symptoms.

Xilonix™ is expected to inhibit tumor growth and metastasis by interrupting crucial signals that drive angiogenesis and invasiveness. The antibody therapy may also block tumor microenvironment infiltration by leukocytes (such as myeloid suppressor cells) that suppress antitumor immunity, enabling better host immune control of the disease. In addition to local effects on the tumor, Xilonix™ is expected to work systemically to correct the metabolic dysregulation, fatigue and anxiety mediated by chronic inflammatory signaling to the central nervous system.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 643 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer
Actual Study Start Date : March 31, 2013
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Arm Intervention/treatment
Experimental: Xilonix
MABp1 administered IV every two weeks, plus best supportive care
Drug: Xilonix
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.
Other Name: MABp1, CA-18C3

Placebo Comparator: Placebo
Placebo administered IV every two weeks, plus best supportive care
Drug: Placebo
Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: baseline to 18 months ]
    The difference in median overall survival will be compared between the two arms.

Secondary Outcome Measures :
  1. Change in Lean Body Mass [ Time Frame: baseline to 8 weeks ]
    Change in LBM as measured by DEXA scan will be compared between the two arms

  2. Quality of life questionnaire [ Time Frame: baseline to 8 weeks ]

  3. Progression Free Survival [ Time Frame: baseline to 18 months ]
    The difference in median PFS will be compared between the two arms

  4. Objective Response Rate [ Time Frame: baseline to 18 months ]
    The ORR will be compared between the two arms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Subjects will not be treated with any radiation, chemotherapy, or investigational agents while enrolled in this protocol.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.
  4. At least 2 weeks since the last previous cancer treatment including: chemotherapy, radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics.
  5. Age ≥ 18 years, male or female subjects.
  6. 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.
  7. Adequate renal function, defined by serum creatinine ≤ 1.5 x ULN.
  8. Adequate hepatic function
  9. Adequate bone marrow function
  10. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
  11. Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed.
  12. Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on the clinical trial for three months.

Exclusion Criteria:

  1. Mechanical obstruction that would prevent adequate oral nutritional intake.
  2. Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
  3. Uncontrolled or significant cardiovascular disease, including:
  4. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
  5. 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.
  6. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV).
  7. Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of hepatitis C RNA.
  8. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).
  9. Receipt of a live (attenuated) vaccine within 1 month prior to Screening
  10. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition of XILONIX™.
  11. Women who are pregnant or breastfeeding.
  12. 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.
  13. Weight loss >20% in the previous 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01767857

Hide Hide 113 study locations
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United States, Alabama
Alabama Oncology, Bruno Cancer Center
Birmingham, Alabama, United States, 35205
Southern Cancer Center, PC
Mobile, Alabama, United States, 36608
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States
United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
California Cancer Associates for Research and Excellence, Inc. (cCARE)
Fresno, California, United States, 93720
St. Jude Medical Center
Fullerton, California, United States, 92835
Cedars-Sinai Medical Center
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center and LAC USC Medical Center
Los Angeles, California, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Stanford Cancer Institute
Palo Alto, California, United States, 94304
American Institute of Research
Whittier, California, United States, 90603
United States, Florida
Advanced Medical Specialists
Miami, Florida, United States
United States, Georgia
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, United States, 31792
United States, Illinois
Swedish Covenant Hospital via Clintell, Inc.
Chicago, Illinois, United States, 60625
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Hines VA Hospital
Hines, Illinois, United States, 60141
Oncology Specialists, SC
Park Ridge, Illinois, United States, 60068
United States, Indiana
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
United States, Kansas
Hutchinson Clinic, P.A.
Hutchinson, Kansas, United States, 67502
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Maryland
The Center for Cancer and Blood Disorders, a Division of Regional Cancer Care Associates LLC.
Bethesda, Maryland, United States, 20817
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Park Nicollet
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
North Shore Hematology Oncology Associates, PC
East Setauket, New York, United States, 11733
Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
Weill Cornell Medical College
New York, New York, United States, 10065
Stony Brook Cancer Center
Stony Brook, New York, United States, 11794
United States, North Carolina
East Carolina Health - Beaufort, Inc. DBA Marion L. Shepard Cancer Center
Washington, North Carolina, United States, 27889
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States, 43560
United States, Oregon
St. Charles Health System, Inc.
Bend, Oregon, United States, 97701
Good Samaritan Hospital Corvallis - SHOC
Corvallis, Oregon, United States, 97330
United States, Pennsylvania
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
United States, South Carolina
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States, 29414
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, United States, 29651
United States, Texas
Texas Oncology
Bedford, Texas, United States, 76022
Coastal Bend Cancer Center
Corpus Christi, Texas, United States, 78404
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75230
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology - Dallas
Dallas, Texas, United States
Texas Oncology - Grapevine
Grapevine, Texas, United States, 76051
Millennium Oncology
Houston, Texas, United States, 77090
Methodist Richardson Cancer Center
Richardson, Texas, United States, 75802
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Scott & White Healthcare
Temple, Texas, United States, 76508
Texas Oncology - Longview and Tyler
Tyler, Texas, United States
University of TX Health Science Center at Tyler
Tyler, Texas, United States
United States, Virginia
Virginia Oncology Associates
Multiple Locations, Virginia, United States
United States, Washington
Providence Regional Medical Center Everett, PRCP - Clinical Research
Everett, Washington, United States, 98201
SCCA - Evergreen Health
Kirkland, Washington, United States, 98034
University of Washington
Multiple Locations, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
SCCA - Group Health
Seattle, Washington, United States, 98112
Australia, New South Wales
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Western Health - Sunshine Hospital
Saint Albans, Victoria, Australia, 3021
Hospital Barmherzige Schwestern Linz
Linz, Austria, 4010
Krankenhaus der Barmherzigen Schwestern Linz
Linz, Austria, 4010
LKH Salzburg 3rd Medical Department with Hematology
Salzburg, Austria, 5020
Klinikum Wels-Grieskirchen GmbH, IV. Internal Department
Wels, Austria, 4600
Grand Hôpital de Charleroi, Grand Rue 3
Charleroi, Hainaut, Belgium, 6000
CHU Dinant Godinne UCL Namur
Yvoir, Namur, Belgium, 5530
Institut Jules Bordet
Brussels, Belgium, 1000
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Antwerp University Hospital
Edegem, Belgium, 2650
Domaine Universitaire du Sart Tilman
Liège, Belgium, 4000
Masarykův onkologický ústav
Brno, Czechia, 65653
Všeobecné fakultní nemocnice v Praze, Onkologická klinika
Praha, Czechia, 12808
Thomayerova nemocnice, Onkologická klinika 1.LF TN Praha
Praha, Czechia, 14059
Fakultní nemocnice v Motole, Komplexní onkologické centrum
Praha, Czechia, 15006
Semmelweis University 1st Dept. Of Internal Medicine, Oncology Division
Budapest, Hungary, 1083
"B" Dept. Of Internal Medicine, National Institute of Oncology
Budapest, Hungary, 1122
Uzsoki Hospital, Dept. of Oncoradiology
Budapest, Hungary, 1145
Dept. Of Oncology, Somogy County Kaposi Mor Teaching Hospital
Kaposvár, Hungary, 7400
Dept. Of Oncology, Tolna County Balassa Janos Hospital
Szekszárd, Hungary, 7100
Rambam Health Care Campus
Haifa, Israel, 31096
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Brescia, Italy, 25124
A.O. Universitaria Arcispedale S.Anna Di Ferrara
Cona, Italy, 44124
Azienda Ospedaliera University Pisana Uo Oncol Medica 2
Pisa, Italy, 56126
U.O. Oncologia Medica
Pontedera, Italy, 56025
San Giovanni Calibita" Fatebenefratelli Hospital
Rome, Italy, 186
Academic Medical Centre Amsterdam
Amsterdam, Netherlands, 1105AZ
Amphia Hospital
Breda, Netherlands, 4819EV
University Medical Center Utrecht Heidelberglaan
Utrecht, Netherlands, 3584CX
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku Odzial Onkologii Klinicznej
Białystok, Poland, 15027
Regionalne Centrum Onkologii Szpitala im. Prof. Franciszka Łukaszczyka
Bydgoszcz, Poland, 85796
Szpital Wojewodzki w Gdyni Sp. Z o.o., Szpital Morski im PCK
Gdynia, Poland, 81519
Przychodnia Lekarska "Komed"
Konin, Poland, 62500
NZOZ Vesalius
Kraków, Poland, 31108
Samodzielny Publiczny ZOZ MSZ z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland, 10228
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej
Warszawa, Poland, 02781
NZOZ Magodent sp z.o.o.
Warszawa, Poland, 04125
Instituto Oncológico Dr. Rosell.
Barcelona, Spain, 8028
Hospital Vall Dhebron Edificio Principal Planta Baja
Barcelona, Spain, 8035
Institut Català d'Oncologia, Hospital Duran i Reynals
Barcelona, Spain, 8907
Institut Català d'Oncologia
Barcelona, Spain, 8916
Hospital ClÃ-nica Benidorm
Benidorm, Spain, 3501
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital 12 De Octubre
Madrid, Spain, 28041
CIOCC, Centro Integral Oncológico Clara Campal
Madrid, Spain, 28050
Hospital Son Llà tzer
Palma, Spain, 7198
Hospital Universitario La Fe, Consultas Externas Oncologia
Valencia, Spain, 46026
Istituto Oncologico della Svizzera Italiania
Bellinzona, Switzerland, 6500
Kantonsspital GraubÃnden
Chur, Switzerland, 7000
United Kingdom
Christie Hospital
Manchester, Greater Manchester, United Kingdom
The Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC Identifier: NCT01767857    
Other Study ID Numbers: 2012-PT023
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Keywords provided by Janssen Research & Development, LLC:
Phase 3
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases