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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Stopped early
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
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United States of America
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Maryland
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United States of America
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Michigan
Country [12] 0 0
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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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United States of America
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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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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
Country [23] 0 0
Austria
State/province [23] 0 0
Linz
Country [24] 0 0
Austria
State/province [24] 0 0
Salzburg
Country [25] 0 0
Austria
State/province [25] 0 0
Wels
Country [26] 0 0
Belgium
State/province [26] 0 0
Hainaut
Country [27] 0 0
Belgium
State/province [27] 0 0
Namur
Country [28] 0 0
Belgium
State/province [28] 0 0
Brussels
Country [29] 0 0
Belgium
State/province [29] 0 0
Edegem
Country [30] 0 0
Belgium
State/province [30] 0 0
Liège
Country [31] 0 0
Czechia
State/province [31] 0 0
Brno
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Kaposvár
Country [35] 0 0
Hungary
State/province [35] 0 0
Szekszárd
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Israel
State/province [36] 0 0
Haifa
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Israel
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Tel Aviv
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Italy
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Brescia
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Italy
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Cona
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Italy
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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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Netherlands
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Breda
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Netherlands
State/province [45] 0 0
Utrecht
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Poland
State/province [46] 0 0
Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdynia
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Poland
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Konin
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Kraków
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Poland
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Olsztyn
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Benidorm
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Palma
Country [57] 0 0
Spain
State/province [57] 0 0
Valencia
Country [58] 0 0
Switzerland
State/province [58] 0 0
Bellinzona
Country [59] 0 0
Switzerland
State/province [59] 0 0
Chur
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Greater Manchester
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Surrey

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01767857