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Metastatic Colorectal CancerPhase 3XCITENCT01767857

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

A Phase 3 study testing Xilonix in people with Metastatic Colorectal Cancer, run by Janssen Research & Development, LLC at 113 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Xilonix
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
643 participants
Where
113 sitesin 13 countries
Study dates
31 Mar 2013to 30 Jun 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
Show all 13Show fewer
  • 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.

Trial locations and contacts

113 sites in 13 countries.

113 sites in 13 countries

United States57 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Texas Oncology

    Bedford, Texas, 76022

  • St. Charles Health System, Inc.

    Bend, Oregon, 97701

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

    Bethesda, Maryland, 20817

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

  • Alabama Oncology, Bruno Cancer Center

    Birmingham, Alabama, 35205

  • Charleston Hematology Oncology Associates, PA

    Charleston, South Carolina, 29414

  • Swedish Covenant Hospital via Clintell, Inc.

    Chicago, Illinois, 60625

  • Oncology Hematology Care

    Cincinnati, Ohio

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78404

  • Good Samaritan Hospital Corvallis - SHOC

    Corvallis, Oregon, 97330

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology - Dallas

    Dallas, Texas

  • North Shore Hematology Oncology Associates, PC

    East Setauket, New York, 11733

  • Providence Regional Medical Center Everett, PRCP - Clinical Research

    Everett, Washington, 98201

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

    Fresno, California, 93720

  • St. Jude Medical Center

    Fullerton, California, 92835

  • Texas Oncology - Grapevine

    Grapevine, Texas, 76051

  • Bon Secours Saint Francis Cancer Center

    Greenville, South Carolina, 29651

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hines VA Hospital

    Hines, Illinois, 60141

  • Millennium Oncology

    Houston, Texas, 77090

  • Hutchinson Clinic, P.A.

    Hutchinson, Kansas, 67502

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • SCCA - Evergreen Health

    Kirkland, Washington, 98034

  • Cedars-Sinai Medical Center

    Los Angeles, California

  • USC Norris Comprehensive Cancer Center and LAC USC Medical Center

    Los Angeles, California

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Advanced Medical Specialists

    Miami, Florida

  • Park Nicollet

    Minneapolis, Minnesota, 55416

  • Southern Cancer Center, PC

    Mobile, Alabama, 36608

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Virginia Oncology Associates

    Multiple Locations, Virginia

  • University of Washington

    Multiple Locations, Washington

  • Northwest Alabama Cancer Center, PC

    Muscle Shoals, Alabama, 35661

  • Weill Cornell Medical College

    New York, New York, 10065

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Oncology Specialists, SC

    Park Ridge, Illinois, 60068

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Methodist Richardson Cancer Center

    Richardson, Texas, 75802

  • Brooke Army Medical Center

    San Antonio, Texas, 78234

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • SCCA - Group Health

    Seattle, Washington, 98112

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • Scott & White Healthcare

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia, 31792

  • Arizona Oncology Associates

    Tucson, Arizona

  • Texas Oncology - Longview and Tyler

    Tyler, Texas

  • University of TX Health Science Center at Tyler

    Tyler, Texas

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

    Washington, North Carolina, 27889

  • American Institute of Research

    Whittier, California, 90603

Other trials in United States

Spain10 sites

  • Instituto Oncológico Dr. Rosell.

    Barcelona, 8028

  • Hospital Vall Dhebron Edificio Principal Planta Baja

    Barcelona, 8035

  • Institut Català d'Oncologia, Hospital Duran i Reynals

    Barcelona, 8907

  • Institut Català d'Oncologia

    Barcelona, 8916

  • Hospital ClÃ-nica Benidorm

    Benidorm, 3501

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital 12 De Octubre

    Madrid, 28041

  • CIOCC, Centro Integral Oncológico Clara Campal

    Madrid, 28050

  • Hospital Son Llà tzer

    Palma, 7198

  • Hospital Universitario La Fe, Consultas Externas Oncologia

    Valencia, 46026

Other trials in Spain

Poland8 sites

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

    Bialystok, 15027

  • Regionalne Centrum Onkologii Szpitala im. Prof. Franciszka Łukaszczyka

    Bydgoszcz, 85796

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

    Gdynia, 81519

  • Przychodnia Lekarska "Komed"

    Konin, 62500

  • NZOZ Vesalius

    Krakow, 31108

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

    Olsztyn, 10228

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

    Warsaw, 02781

  • NZOZ Magodent sp z.o.o.

    Warsaw, 04125

Other trials in Poland

Belgium6 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi, Grand Rue 3

    Charleroi, Hainaut, 6000

  • Antwerp University Hospital

    Edegem, 2650

  • Domaine Universitaire du Sart Tilman

    Liège, 4000

  • CHU Dinant Godinne UCL Namur

    Yvoir, Namur, 5530

Other trials in Belgium

Australia5 sites

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Western Health - Sunshine Hospital

    Saint Albans, Victoria, 3021

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Hungary5 sites

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

    Budapest, 1083

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

    Budapest, 1122

  • Uzsoki Hospital, Dept. of Oncoradiology

    Budapest, 1145

  • Dept. Of Oncology, Somogy County Kaposi Mor Teaching Hospital

    Kaposvár, 7400

  • Dept. Of Oncology, Tolna County Balassa Janos Hospital

    Szekszárd, 7100

Other trials in Hungary

Italy5 sites

  • FONDAZIONE POLIAMBULANZA â€" ISTITUTO OSPEDALIERO

    Brescia, 25124

  • A.O. Universitaria Arcispedale S.Anna Di Ferrara

    Cona, 44124

  • Azienda Ospedaliera University Pisana Uo Oncol Medica 2

    Pisa, 56126

  • U.O. Oncologia Medica

    Pontedera, 56025

  • San Giovanni Calibita" Fatebenefratelli Hospital

    Rome, 186

Other trials in Italy

Austria4 sites

  • Hospital Barmherzige Schwestern Linz

    Linz, 4010

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, 4010

  • LKH Salzburg 3rd Medical Department with Hematology

    Salzburg, 5020

  • Klinikum Wels-Grieskirchen GmbH, IV. Internal Department

    Wels, 4600

Other trials in Austria

Czechia4 sites

  • Masarykův onkologický ústav

    Brno, 65653

  • Všeobecné fakultní nemocnice v Praze, Onkologická klinika

    Prague, 12808

  • Thomayerova nemocnice, Onkologická klinika 1.LF TN Praha

    Prague, 14059

  • Fakultní nemocnice v Motole, Komplexní onkologické centrum

    Prague, 15006

Other trials in Czechia

Netherlands3 sites

  • Academic Medical Centre Amsterdam

    Amsterdam, 1105AZ

  • Amphia Hospital

    Breda, 4819EV

  • University Medical Center Utrecht Heidelberglaan

    Utrecht, 3584CX

Other trials in Netherlands

Israel2 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Switzerland2 sites

  • Istituto Oncologico della Svizzera Italiania

    Bellinzona, 6500

  • Kantonsspital GraubÃnden

    Chur, 7000

Other trials in Switzerland

United Kingdom2 sites

  • Christie Hospital

    Manchester, Greater Manchester

  • The Royal Marsden Hospital

    Sutton, Surrey

Other trials in United Kingdom

About this study

Official title: Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer

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.

Read the 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.

Being tested
Xilonix, Placebo
Keywords
Pivotal, Colorectal, Survival, Phase 3
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XilonixDrug

    Also called MABp1, CA-18C3

    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.

  • PlaceboDrug

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

Study groups in NCT01767857
Study groupRoleWhat they receive
XilonixExperimentalMABp1 administered IV every two weeks, plus best supportive care
Receives: Drug: Xilonix
PlaceboPlacebo comparatorPlacebo administered IV every two weeks, plus best supportive care
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 18 months

Secondary outcomes (6)

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

    Change from baseline in LBM as measured by Dexa scans was reported. DEXA is an X-ray imaging modality used to determine the mass of one material in the presence of another material, using the knowledge of their unique X-ray attenuation at different energies.

    Measured: Baseline and Week 8

  2. 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)

    The EORTC QLQ-C30 questionnaire incorporates nine multi-item scales: 5 functional scales (physical, cognitive, role, emotional, and social); 3 symptom scales (pain, fatigue, and appetite loss) and a Global Health Status/QoL scale. Each item, except Global Health Status, is answered on a four-point scale (1-4): 1-not at all, 2-a little, 3-quite a bit, 4-very much. Response to Global Health Status is measured on a 1 to 7 scale. "1" being very poor and "7" being excellent. Each scale (symptom scale [pain, fatigue, and appetite loss] and Global Health Status/Quality of Life [QoL] scale) was linearly transformed to be in range from 0-100 where a higher score represents good health status, while lower scores indicate poor health status. As planned, the data for symptom scales (pain, fatigue, appetite loss) and a Global Health Status/QoL scale was evaluated and reported.

    Measured: Baseline and Week 8

  3. Change From Baseline in Platelet Counts

    Change from baseline in platelet counts up to Week 8 was evaluated.

    Measured: Baseline and Week 8

  4. Progression Free Survival (PFS)

    PFS was defined as time from randomization to tumor progression or death. Progressive Disease defined as increase in tumor burden greater than or equals to (>=) 25 (%) percent relative to nadir (minimum recorded tumor burden) confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented. Participants surviving without disease progression at end of study were censored. PFS was compared by Kaplan-Meier method using log-rank test.

    Measured: Up to 18 Months

  5. Percentage of Participants With Objective Response (OR)

    The percentage of OR was estimated by dividing the total number of confirmed complete response (CR) and partial response (PR) by the total number of participants randomized where CR was complete disappearance of all lesions (whether measurable or not, and no new lesions); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented and PR was decrease in tumor burden >= 50 % relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation.

    Measured: Up to 18 months

  6. Percentage of Participants With Disease Control

    Percentage of participants who achieved disease control was estimated by dividing the total number of confirmed CRs, PRs and stable disease (SD) by the total number of participants randomized where CR was complete disappearance of all lesions (whether measurable or not, and no new lesions); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented, PR was decrease in tumor burden >= 50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation and SD defined as not meeting criteria for CR and PR, in absence of Progressive Disease (increase in tumor burden >= 25 % relative to nadir (minimum recorded tumor burden) confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented).

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2013 (estimated)
  2. Study start31 Mar 2013
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Why it stopped: The study crossed the prospective futility boundary of primary endpoint

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
643 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01767857
Sponsor's protocol ID
2012-PT023
Acronym
XCITE
Status last verified
Jun 2021
First submitted
8 Jan 2013
Last updated
29 Jun 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24746841

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xilonix in people with Metastatic Colorectal Cancer, run by Janssen Research & Development, LLC at 113 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Spain, Poland, Belgium, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01767857, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.

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