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TerminatedNCT01767857XCITEUpdated Jun 29, 2021Results posted

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

A Phase 3 interventional study of Xilonix and Placebo in Metastatic Colorectal Cancer, sponsored by Janssen Research & Development, LLC. Terminated at 113 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-29.

Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment

Why this study was terminated
The study crossed the prospective futility boundary of primary endpoint
Phase
Phase 3
Study type
Interventional
Enrollment
643
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Metastatic Colorectal Cancer

Keywords

  • Pivotal
  • Colorectal
  • Survival
  • Phase 3
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 643 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
643 participants (actual)

Study arms

  • Experimental
    Xilonix

    MABp1 administered IV every two weeks, plus best supportive care

    Drug: Xilonix

  • Placebo comparator
    Placebo

    Placebo administered IV every two weeks, plus best supportive care

    Drug: Placebo

Interventions

  • DrugXilonix

    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

  • DrugPlacebo

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

06

What researchers measure

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.

    Time frame: Up to 18 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: Baseline and Week 8

  3. Change From Baseline in Platelet Counts

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: Up to 18 months

07

Results

Posted Jun 29, 2021

Participant flow

Participant flow — Overall Study
MilestoneXilonixPlacebo
Started430213
Treated411200
Completed00
Not completed430213
Withdrew: Adverse event277
Withdrew: Death2813
Withdrew: Lack of efficacy299151
Withdrew: Lost to follow-up11
Withdrew: Withdrawal by subject3818
Withdrew: Physician decision1710
Withdrew: Protocol terminated10
Withdrew: Randomized but never treated1913

Outcome measures

PrimaryOverall 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.

Time frame:
Up to 18 months
Reported as:
Median · Months
Overall Survival (OS)
MonthsXilonixPlacebo
Overall Survival (OS)5.6 (4.9 to 6.2)5.4 (4.6 to 6.2)
Statistical analysis
  • Xilonix vs Placebo · Log Rank · p = 0.613
SecondaryChange 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.

Time frame:
Baseline and Week 8
Reported as:
Least squares mean · kilogram (kg)
Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans
kilogram (kg)XilonixPlacebo
Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans0.51 ± 0.158-0.21 ± 0.231
Statistical analysis
  • Xilonix vs Placebo · ANCOVA · p = 0.011
SecondaryChange 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.

Time frame:
Baseline and Week 8
Reported as:
Least squares mean · Units on a scale
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)
Units on a scaleXilonixPlacebo
Global Health Status/Qol-6.64 ± 1.392-8.16 ± 2.041
Pain8.50 ± 1.70710.27 ± 2.503
Fatigue7.42 ± 1.5168.82 ± 2.223
Appetite Loss9.34 ± 2.01011.84 ± 2.947
Statistical analysis
  • Xilonix vs Placebo · ANCOVA · p = 0.541
  • Xilonix vs Placebo · ANCOVA · p = 0.560
  • Xilonix vs Placebo · ANCOVA · p = 0.603
  • Xilonix vs Placebo · ANCOVA · p = 0.485
SecondaryChange From Baseline in Platelet Counts

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

Time frame:
Baseline and Week 8
Reported as:
Least squares mean · 1000 cells/cubic millimeter
Change From Baseline in Platelet Counts
1000 cells/cubic millimeterXilonixPlacebo
Change From Baseline in Platelet Counts5.50 ± 4.72116.19 ± 7.082
Statistical analysis
  • Xilonix vs Placebo · ANCOVA · p = 0.210
SecondaryProgression 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.

Time frame:
Up to 18 Months
Reported as:
Median · Months
Progression Free Survival (PFS)
MonthsXilonixPlacebo
Progression Free Survival (PFS)2.1 (2.1 to 2.1)2.1 (2.0 to 2.1)
Statistical analysis
  • Xilonix vs Placebo · Log Rank · p = 0.768
SecondaryPercentage 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.

Time frame:
Up to 18 months
Reported as:
Number · Percentage of Participants
Percentage of Participants With Objective Response (OR)
Percentage of ParticipantsXilonixPlacebo
Percentage of Participants With Objective Response (OR)00
SecondaryPercentage 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).

Time frame:
Up to 18 months
Reported as:
Number · Percentage of Participants
Percentage of Participants With Disease Control
Percentage of ParticipantsXilonixPlacebo
Percentage of Participants With Disease Control2527.3

Adverse events

Collected over Up to 18 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Xilonix28/411 (6.8%)169/411 (41.1%)324/411 (78.8%)
Placebo13/200 (6.5%)84/200 (42%)167/200 (83.5%)
Most frequent serious events
Showing 10 of 137
Most frequent serious events
EventXilonixPlacebo
Disease ProgressionGeneral disorders21/41114/200
DyspnoeaRespiratory, thoracic and mediastinal disorders12/4119/200
Abdominal PainGastrointestinal disorders9/4116/200
Hepatic FailureHepatobiliary disorders11/4113/200
AnaemiaBlood and lymphatic system disorders3/4115/200
General Physical Health DeteriorationGeneral disorders8/4115/200
Colorectal CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)8/4115/200
SepsisInfections and infestations3/4114/200
Metastases to Central Nervous SystemNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/4114/200
Acute Kidney InjuryRenal and urinary disorders8/4111/200
Most frequent other events
Showing 10 of 22
Most frequent other events
EventXilonixPlacebo
FatigueGeneral disorders109/41160/200
Decreased AppetiteMetabolism and nutrition disorders84/41151/200
NauseaGastrointestinal disorders79/41146/200
Abdominal PainGastrointestinal disorders78/41141/200
AstheniaGeneral disorders63/41135/200
ConstipationGastrointestinal disorders51/41131/200
PyrexiaGeneral disorders38/41127/200
Back PainMusculoskeletal and connective tissue disorders44/41127/200
CoughRespiratory, thoracic and mediastinal disorders40/41127/200
DyspnoeaRespiratory, thoracic and mediastinal disorders49/41127/200

Baseline characteristics

Baseline analysis population included all participants who were randomized and received at least one infusion of study drug.

Age, Continuous
Age, Continuous(years)XilonixPlaceboTotal
Mean62.9 ± 10.1461.1 ± 9.9862.3 ± 10.11
Sex: Female, Male
Sex: Female, Male(Participants)XilonixPlaceboTotal
Female15994253
Male252106358
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)XilonixPlaceboTotal
American Indian or Alaska Native000
Asian15217
Black or African American20828
Native Hawaiian or Other Pacific Islander000
White355186541
More than one race000
Unknown or Not Reported000
Other21425
Region of Enrollment
Region of Enrollment(Participants)XilonixPlaceboTotal
Australia18725
Austria12315
Belgium492776
Czech Republic8311
England7310
Hungary8311
Israel437
Italy11718
Netherlands8412
Poland301848
Spain11855173
Switzerland336
USA13564199
Age (years)
Age (years)(Participants)XilonixPlaceboTotal
< 65 years229122351
Between 65 and 75 years14164205
> 75 years411455
Missing000
08

Study locations

113 sites
  • Alabama Oncology, Bruno Cancer Center
    Birmingham, Alabama 35205, United States
  • Southern Cancer Center, PC
    Mobile, Alabama 36608, United States
  • Northwest Alabama Cancer Center, PC
    Muscle Shoals, Alabama 35661, United States
  • Arizona Oncology Associates
    Tucson, Arizona, United States
  • Pacific Cancer Medical Center, Inc.
    Anaheim, California 92801, United States
  • California Cancer Associates for Research and Excellence, Inc. (cCARE)
    Fresno, California 93720, United States
  • St. Jude Medical Center
    Fullerton, California 92835, United States
  • 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 93030, United States
  • Stanford Cancer Institute
    Palo Alto, California 94304, United States
  • American Institute of Research
    Whittier, California 90603, United States
  • Advanced Medical Specialists
    Miami, Florida, United States
  • Lewis Hall Singletary Oncology Center
    Thomasville, Georgia 31792, United States
  • Swedish Covenant Hospital via Clintell, Inc.
    Chicago, Illinois 60625, United States
  • Ingalls Memorial Hospital
    Harvey, Illinois 60426, United States
  • Hines VA Hospital
    Hines, Illinois 60141, United States
  • Oncology Specialists, SC
    Park Ridge, Illinois 60068, United States
  • Franciscan St. Francis Health
    Indianapolis, Indiana 46237, United States
  • Hutchinson Clinic, P.A.
    Hutchinson, Kansas 67502, United States
  • James Graham Brown Cancer Center
    Louisville, Kentucky 40202, United States
  • The Center for Cancer and Blood Disorders, a Division of Regional Cancer Care Associates LLC.
    Bethesda, Maryland 20817, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Park Nicollet
    Minneapolis, Minnesota 55416, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • North Shore Hematology Oncology Associates, PC
    East Setauket, New York 11733, United States
  • Northern Westchester Hospital
    Mount Kisco, New York 10549, United States
  • Weill Cornell Medical College
    New York, New York 10065, United States
  • Stony Brook Cancer Center
    Stony Brook, New York 11794, United States
  • East Carolina Health - Beaufort, Inc. DBA Marion L. Shepard Cancer Center
    Washington, North Carolina 27889, United States
  • Oncology Hematology Care
    Cincinnati, Ohio, United States
  • ProMedica Flower Hospital
    Sylvania, Ohio 43560, United States
  • St. Charles Health System, Inc.
    Bend, Oregon 97701, United States
  • Good Samaritan Hospital Corvallis - SHOC
    Corvallis, Oregon 97330, United States
  • St. Luke's University Health Network
    Bethlehem, Pennsylvania 18015, United States
  • Albert Einstein Cancer Center
    Philadelphia, Pennsylvania 19141, United States
  • Charleston Hematology Oncology Associates, PA
    Charleston, South Carolina 29414, United States
  • Bon Secours Saint Francis Cancer Center
    Greenville, South Carolina 29651, United States
  • Texas Oncology
    Bedford, Texas 76022, United States
  • Coastal Bend Cancer Center
    Corpus Christi, Texas 78404, United States
  • Mary Crowley Cancer Research Center
    Dallas, Texas 75230, United States
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
    Dallas, Texas 75246, United States
  • Texas Oncology - Dallas
    Dallas, Texas, United States
  • Texas Oncology - Grapevine
    Grapevine, Texas 76051, United States
  • Millennium Oncology
    Houston, Texas 77090, United States
  • Methodist Richardson Cancer Center
    Richardson, Texas 75802, United States
  • Brooke Army Medical Center
    San Antonio, Texas 78234, United States
  • Scott & White Healthcare
    Temple, Texas 76508, United States
  • Texas Oncology - Longview and Tyler
    Tyler, Texas, United States
  • University of TX Health Science Center at Tyler
    Tyler, Texas, United States
  • Virginia Oncology Associates
    Multiple Locations, Virginia, United States
  • Providence Regional Medical Center Everett, PRCP - Clinical Research
    Everett, Washington 98201, United States
  • SCCA - Evergreen Health
    Kirkland, Washington 98034, United States
  • University of Washington
    Multiple Locations, Washington, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • SCCA - Group Health
    Seattle, Washington 98112, United States
  • Royal North Shore Hospital
    St Leonards, New South Wales 2065, Australia
  • Royal Brisbane & Women's Hospital
    Herston, Queensland 4029, Australia
  • Lyell McEwin Hospital
    Elizabeth Vale, South Australia 5112, Australia
  • Royal Hobart Hospital
    Hobart, Tasmania 7000, Australia
  • Western Health - Sunshine Hospital
    Saint Albans, Victoria 3021, Australia
  • Hospital Barmherzige Schwestern Linz
    Linz, 4010, Austria
  • Krankenhaus der Barmherzigen Schwestern Linz
    Linz, 4010, Austria
  • LKH Salzburg 3rd Medical Department with Hematology
    Salzburg, 5020, Austria
  • Klinikum Wels-Grieskirchen GmbH, IV. Internal Department
    Wels, 4600, Austria
  • Grand Hôpital de Charleroi, Grand Rue 3
    Charleroi, Hainaut 6000, Belgium
  • CHU Dinant Godinne UCL Namur
    Yvoir, Namur 5530, Belgium
  • Institut Jules Bordet
    Brussels, 1000, Belgium
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
  • Antwerp University Hospital
    Edegem, 2650, Belgium
  • Domaine Universitaire du Sart Tilman
    Liège, 4000, Belgium
  • Masarykův onkologický ústav
    Brno, 65653, Czechia
  • Všeobecné fakultní nemocnice v Praze, Onkologická klinika
    Praha, 12808, Czechia
  • Thomayerova nemocnice, Onkologická klinika 1.LF TN Praha
    Praha, 14059, Czechia
  • Fakultní nemocnice v Motole, Komplexní onkologické centrum
    Praha, 15006, Czechia
  • Semmelweis University 1st Dept. Of Internal Medicine, Oncology Division
    Budapest, 1083, Hungary
  • "B" Dept. Of Internal Medicine, National Institute of Oncology
    Budapest, 1122, Hungary
  • Uzsoki Hospital, Dept. of Oncoradiology
    Budapest, 1145, Hungary
  • Dept. Of Oncology, Somogy County Kaposi Mor Teaching Hospital
    Kaposvár, 7400, Hungary
  • Dept. Of Oncology, Tolna County Balassa Janos Hospital
    Szekszárd, 7100, Hungary
  • Rambam Health Care Campus
    Haifa, 31096, Israel
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
  • FONDAZIONE POLIAMBULANZA â€" ISTITUTO OSPEDALIERO
    Brescia, 25124, Italy
  • A.O. Universitaria Arcispedale S.Anna Di Ferrara
    Cona, 44124, Italy
  • Azienda Ospedaliera University Pisana Uo Oncol Medica 2
    Pisa, 56126, Italy
  • U.O. Oncologia Medica
    Pontedera, 56025, Italy
  • San Giovanni Calibita" Fatebenefratelli Hospital
    Rome, 186, Italy
  • Academic Medical Centre Amsterdam
    Amsterdam, 1105AZ, Netherlands
  • Amphia Hospital
    Breda, 4819EV, Netherlands
  • University Medical Center Utrecht Heidelberglaan
    Utrecht, 3584CX, Netherlands
  • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku Odzial Onkologii Klinicznej
    Białystok, 15027, Poland
  • Regionalne Centrum Onkologii Szpitala im. Prof. Franciszka Łukaszczyka
    Bydgoszcz, 85796, Poland
  • Szpital Wojewodzki w Gdyni Sp. Z o.o., Szpital Morski im PCK
    Gdynia, 81519, Poland
  • Przychodnia Lekarska "Komed"
    Konin, 62500, Poland
  • NZOZ Vesalius
    Kraków, 31108, Poland
  • Samodzielny Publiczny ZOZ MSZ z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
    Olsztyn, 10228, Poland
  • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej
    Warszawa, 02781, Poland
  • NZOZ Magodent sp z.o.o.
    Warszawa, 04125, Poland
  • Instituto Oncológico Dr. Rosell.
    Barcelona, 8028, Spain

Showing the first 100 of 113 sites across 13 countries.

09

References and documents

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 ↗

Study documents

  • Study protocol · Jun 5, 2017
  • Statistical analysis plan · Aug 18, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01767857
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Jan 14, 2013
Start date
Mar 31, 2013
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Results posted
Jun 29, 2021
Last update
Jun 29, 2021

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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