Symptomatic Colorectal Cancer MedDRA version: 17.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: XILONIX™
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: N/A
Current Sponsor code: XILONIX
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Conce
Sponsors
XBiotech Germany GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are included in the study if they meet all of the following 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 failed both an oxaliplatin (oxaliplatin may have been in the adjuvant setting) and an irinotecan based regimen. 2. Symptomatic Disease: One symptom from each domain (metabolic and functional) must be present. • Evidence of metabolic dysfunction, defined as the presence of one or more of the following: • Any degree (up to 20%) of unintentional total body weight loss in the previous 6 months • Serum Interleukin 6 levels =10 pg/ml • Evidence of reduced function or presence of cancer related symptoms as determined by EORTC QLQ-C30. • Appetite reduction, with a score of >10 • Presence of fatigue, with a score of >10 • Presence of Pain, with a score of >10 • Decreased Role, Emotional and Social function, with a score of =65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: Subjects with ANY of the following will be excluded from the study: 1. Mechanical obstruction that would prevent adequate oral nutritional intake. 2. >20% total body weight loss in the previous 6 months. 3. Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy. 4. Uncontrolled or significant cardiovascular disease, including: • A myocardial infarction within the past 6 months. • Uncontrolled angina within the past 3 months. • Congestive heart failure within the past 3 months, if defined as NYHC-II. • Diagnosed or suspected congenital long QT syndrome. • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes). • Any history of second or third degree heart block (may be eligible if currently have a pacemaker). • Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic). 5. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent. 6. 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. 7. Subjects who have received extensive prior radiation therapy to the bone marrow. Extensive radiation therapy is defined as treatment of more than one axial bony metastasis. However for subjects with rectal cancer pelvic irradiation, in addition to treatment of one axial bony metastasis, is acceptable. 8. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV). 9. Known hepatitis B surface antigen and/or positive hepatitis C antibody or known history of infection. 10. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA). 11. Receipt of a live (attenuated) vaccine within 1 month prior to Randomization 12. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to Xilonix™ or any component of its formulations. 13. Women who are pregnant or breastfeeding. 14. 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 randomization, for the duration of the study, and for at least 3 months after the last dose of study medication. 15.History of progressive multifocal leukoencephalopathy or other demyelinating disease. 16.Subjects on immunosuppressive therapy, including transplant patients. 17. Subjects with known brain metastases. Subjects with symptoms of brain metastases during screening should undergo CT imaging prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Efficacy Endpoint: • The primary endpoint of this study will be the objective response rate (ORR), a composite measure consisting of change in lean body mass (LBM) and change in quality of life, from screening to week 8. The ORR will be defined as a stabilization or positive (=0 kg) change in lean body mass (LBM)—as assessed by dual-energy X-ray absorptiometry (DEXA) scan, and improvement or no worsening (=0 score point change) on any two of the three symptom scale measures (fatigue, pain, appetite) of EORTC QLQ-C30.;Secondary Objective: Secondary Endpoints: • Secondary efficacy endpoints include measures of key cancer symptoms, as well as pharmacodynamics parameters. Parameters to be measured are: (1) change in functional scales and (2) global QoL as assessed by the EORTC QLQ-C30 questionnaire at screening and 8 week follow-up; (3) reduction in serum IL-6; and (4) stabilization of platelet count at 8 week compared to screening. • Safety and tolerability of Xilonix™ as compared to placebo control.;Primary end point(s): The primary endpoint of this study will be the objective response rate (ORR), a composite measure consisting of change in lean body mass (LBM) and change in quality of life, from screening to week 8. The ORR will be defined as a stabilization or positive (=0 kg) change in lean body mass (LBM)—as assessed by dual-energy X-ray absorptiometry (DEXA) scan, and improvement or no worsening (=0 score point change) on any two of the three symptom scale measures (fatigue, pain, appetite) of EORTC QLQ-C30.;Timepoint(s) of evaluation of this end point: Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints include measures of key cancer symptoms, as well as pharmacodynamics parameters. Parameters to be measured are: (1) change in functional scales and (2) global QoL as assessed by the EORTC QLQ-C30 questionnaire at screening and 8 week follow-up; (3) reduction in serum IL-6; and (4) stabilization of platelet count at 8 week compared to screening. • Safety and tolerability of Xilonix™ as compared to placebo control.;Timepoint(s) of evaluation of this end point: Week 8 | — |
Countries
Argentina, Bulgaria, Czech Republic, France, Georgia, Germany, Hungary, Poland, Russian Federation, United Kingdom
Contacts
Public ContactClinical Trial Information
XBiotech USA, Inc.
Outcome results
None listed