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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01767857
Recruitment Status : Terminated (The study crossed the prospective futility boundary of primary endpoint)
First Posted : January 14, 2013
Last Update Posted : August 29, 2017
Information provided by (Responsible Party):
XBiotech, Inc.

Tracking Information
First Submitted Date  ICMJE January 8, 2013
First Posted Date  ICMJE January 14, 2013
Last Update Posted Date August 29, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2013)
Overall Survival [ Time Frame: baseline to 18 months ]
The difference in median overall survival will be compared between the two arms.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • Change in Lean Body Mass [ Time Frame: baseline to 8 weeks ]
    Change in LBM as measured by DEXA scan will be compared between the two arms
  • Quality of life questionnaire [ Time Frame: baseline to 8 weeks ]
  • Progression Free Survival [ Time Frame: baseline to 18 months ]
    The difference in median PFS will be compared between the two arms
  • Objective Response Rate [ Time Frame: baseline to 18 months ]
    The ORR will be compared between the two arms
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2013)
  • Change in Lean Body Tissue [ Time Frame: baseline to 8 weeks ]
  • Quality of life questionnaire [ Time Frame: baseline to 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
Official Title  ICMJE Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: 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.
    Other Name: MABp1, CA-18C3
  • Drug: Placebo
    Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.
Study Arms  ICMJE
  • Experimental: Xilonix
    MABp1 administered IV every two weeks, plus best supportive care
    Intervention: Drug: Xilonix
  • Placebo Comparator: Placebo
    Placebo administered IV every two weeks, plus best supportive care
    Intervention: Drug: Placebo
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-1α 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 22, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2013)
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Czechia,   Hungary,   Israel,   Italy,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01767857
Other Study ID Numbers  ICMJE 2012-PT023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party XBiotech, Inc.
Study Sponsor  ICMJE XBiotech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: George Fisher, M.D., Ph.D. Stanford University
PRS Account XBiotech, Inc.
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP