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

Primary Purpose

Metastatic Colorectal Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Xilonix
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Pivotal, Colorectal, Survival, Phase 3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Oncology, Bruno Cancer Center
  • Southern Cancer Center, PC
  • Northwest Alabama Cancer Center, PC
  • Arizona Oncology Associates
  • Pacific Cancer Medical Center, Inc.
  • California Cancer Associates for Research and Excellence, Inc. (cCARE)
  • St. Jude Medical Center
  • Cedars-Sinai Medical Center
  • USC Norris Comprehensive Cancer Center and LAC USC Medical Center
  • Ventura County Hematology-Oncology Specialists
  • Stanford Cancer Institute
  • American Institute of Research
  • Advanced Medical Specialists
  • Lewis Hall Singletary Oncology Center
  • Swedish Covenant Hospital via Clintell, Inc.
  • Ingalls Memorial Hospital
  • Hines VA Hospital
  • Oncology Specialists, SC
  • Franciscan St. Francis Health
  • Hutchinson Clinic, P.A.
  • James Graham Brown Cancer Center
  • The Center for Cancer and Blood Disorders, a Division of Regional Cancer Care Associates LLC.
  • University of Michigan
  • Park Nicollet
  • Washington University School of Medicine
  • Montefiore Medical Center
  • North Shore Hematology Oncology Associates, PC
  • Northern Westchester Hospital
  • Weill Cornell Medical College
  • Stony Brook Cancer Center
  • East Carolina Health - Beaufort, Inc. DBA Marion L. Shepard Cancer Center
  • Oncology Hematology Care
  • ProMedica Flower Hospital
  • St. Charles Health System, Inc.
  • Good Samaritan Hospital Corvallis - SHOC
  • St. Luke's University Health Network
  • Albert Einstein Cancer Center
  • Charleston Hematology Oncology Associates, PA
  • Bon Secours Saint Francis Cancer Center
  • Texas Oncology
  • Coastal Bend Cancer Center
  • Mary Crowley Cancer Research Center
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Texas Oncology - Dallas
  • Texas Oncology - Grapevine
  • Millennium Oncology
  • Methodist Richardson Cancer Center
  • Brooke Army Medical Center
  • Scott & White Healthcare
  • Texas Oncology - Longview and Tyler
  • University of TX Health Science Center at Tyler
  • Virginia Oncology Associates
  • Providence Regional Medical Center Everett, PRCP - Clinical Research
  • SCCA - Evergreen Health
  • University of Washington
  • Seattle Cancer Care Alliance
  • SCCA - Group Health
  • Royal North Shore Hospital
  • Royal Brisbane & Women's Hospital
  • Lyell McEwin Hospital
  • Royal Hobart Hospital
  • Western Health - Sunshine Hospital
  • Hospital Barmherzige Schwestern Linz
  • Krankenhaus der Barmherzigen Schwestern Linz
  • LKH Salzburg 3rd Medical Department with Hematology
  • Klinikum Wels-Grieskirchen GmbH, IV. Internal Department
  • Grand Hôpital de Charleroi, Grand Rue 3
  • CHU Dinant Godinne UCL Namur
  • Institut Jules Bordet
  • Cliniques Universitaires Saint-Luc
  • Antwerp University Hospital
  • Domaine Universitaire du Sart Tilman
  • Masarykův onkologický ústav
  • Všeobecné fakultní nemocnice v Praze, Onkologická klinika
  • Thomayerova nemocnice, Onkologická klinika 1.LF TN Praha
  • Fakultní nemocnice v Motole, Komplexní onkologické centrum
  • Semmelweis University 1st Dept. Of Internal Medicine, Oncology Division
  • "B" Dept. Of Internal Medicine, National Institute of Oncology
  • Uzsoki Hospital, Dept. of Oncoradiology
  • Dept. Of Oncology, Somogy County Kaposi Mor Teaching Hospital
  • Dept. Of Oncology, Tolna County Balassa Janos Hospital
  • Rambam Health Care Campus
  • Tel Aviv Sourasky Medical Center
  • FONDAZIONE POLIAMBULANZA â€" ISTITUTO OSPEDALIERO
  • A.O. Universitaria Arcispedale S.Anna Di Ferrara
  • Azienda Ospedaliera University Pisana Uo Oncol Medica 2
  • U.O. Oncologia Medica
  • San Giovanni Calibita" Fatebenefratelli Hospital
  • Academic Medical Centre Amsterdam
  • Amphia Hospital
  • University Medical Center Utrecht Heidelberglaan
  • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku Odzial Onkologii Klinicznej
  • Regionalne Centrum Onkologii Szpitala im. Prof. Franciszka Łukaszczyka
  • Szpital Wojewodzki w Gdyni Sp. Z o.o., Szpital Morski im PCK
  • Przychodnia Lekarska "Komed"
  • NZOZ Vesalius
  • Samodzielny Publiczny ZOZ MSZ z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
  • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej
  • NZOZ Magodent sp z.o.o.
  • Instituto Oncológico Dr. Rosell.
  • Hospital Vall Dhebron Edificio Principal Planta Baja
  • Institut Català d'Oncologia, Hospital Duran i Reynals
  • Institut Català d'Oncologia
  • Hospital ClÃ-nica Benidorm
  • Hospital Universitario Ramon y Cajal
  • Hospital 12 De Octubre
  • CIOCC, Centro Integral Oncológico Clara Campal
  • Hospital Son Llà tzer
  • Hospital Universitario La Fe, Consultas Externas Oncologia
  • Istituto Oncologico della Svizzera Italiania
  • Kantonsspital GraubÃnden
  • Christie Hospital
  • The Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xilonix

Placebo

Arm Description

MABp1 administered IV every two weeks, plus best supportive care

Placebo administered IV every two weeks, plus best supportive care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change From Baseline in Platelet Counts
Change from baseline in platelet counts up to Week 8 was evaluated.
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.
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.
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).

Full Information

First Posted
January 8, 2013
Last Updated
June 28, 2021
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01767857
Brief Title
A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
Acronym
XCITE
Official Title
Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
The study crossed the prospective futility boundary of primary endpoint
Study Start Date
March 31, 2013 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Pivotal, Colorectal, Survival, Phase 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
643 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xilonix
Arm Type
Experimental
Arm Description
MABp1 administered IV every two weeks, plus best supportive care
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV every two weeks, plus best supportive care
Intervention Type
Drug
Intervention Name(s)
Xilonix
Other Intervention Name(s)
MABp1, CA-18C3
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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 Outcome Measure Information:
Title
Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans
Description
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
Title
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)
Description
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
Title
Change From Baseline in Platelet Counts
Description
Change from baseline in platelet counts up to Week 8 was evaluated.
Time Frame
Baseline and Week 8
Title
Progression Free Survival (PFS)
Description
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
Title
Percentage of Participants With Objective Response (OR)
Description
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
Title
Percentage of Participants With Disease Control
Description
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

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
24746841
Citation
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.
Results Reference
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A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer

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