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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01767857




Registration number
NCT01767857
Ethics application status
Date submitted
8/01/2013
Date registered
14/01/2013
Date last updated
29/06/2021

Titles & IDs
Public title
A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
Scientific title
Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer
Secondary ID [1] 0 0
2012-PT023
Universal Trial Number (UTN)
Trial acronym
XCITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xilonix
Treatment: Drugs - Placebo

Experimental: Xilonix - MABp1 administered IV every two weeks, plus best supportive care

Placebo Comparator: Placebo - Placebo administered IV every two weeks, plus best supportive care


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

Treatment: Drugs: Placebo
Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 18 months
Secondary outcome [1] 0 0
Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans
Timepoint [1] 0 0
Baseline and Week 8
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Baseline and Week 8
Secondary outcome [3] 0 0
Change From Baseline in Platelet Counts
Timepoint [3] 0 0
Baseline and Week 8
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
Up to 18 Months
Secondary outcome [5] 0 0
Percentage of Participants With Objective Response (OR)
Timepoint [5] 0 0
Up to 18 months
Secondary outcome [6] 0 0
Percentage of Participants With Disease Control
Timepoint [6] 0 0
Up to 18 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
Accrual to date
Final
643
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [3] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
Western Health - Sunshine Hospital - Saint Albans
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3021 - Saint Albans
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Maryland
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Michigan
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Washington
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Wels
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Belgium
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Hainaut
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Belgium
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Namur
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Liège
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Czechia
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Brno
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Czechia
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Praha
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Hungary
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Budapest
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Hungary
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Kaposvár
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Hungary
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Szekszárd
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Israel
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Haifa
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Israel
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Tel Aviv
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Brescia
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Cona
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Pisa
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Italy
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Pontedera
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Italy
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Rome
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Netherlands
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Amsterdam
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Breda
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Netherlands
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Utrecht
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Poland
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Bialystok
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Bydgoszcz
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Gdynia
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Konin
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Kraków
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Olsztyn
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Warszawa
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Spain
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Barcelona
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Benidorm
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Spain
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Madrid
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Spain
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Palma
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Spain
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Valencia
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Switzerland
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Bellinzona
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Switzerland
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Chur
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United Kingdom
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Greater Manchester
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United Kingdom
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01767857
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01767857