A Study Evaluating Xilonix™ in Symptomatic Colorectal Cancer Patients Refractory To Standard Therapy

Phase 1

• Conditions: Symptomatic Colorectal Cancer; MedDRA version: 19.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000550-12-PL
• Lead Sponsor: XBiotech Germany GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-12
• Last Update Posted: 16 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 335

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 < 90.
3. Eastern Cooperative Oncology Group (ECOG) performance status 1 or
2.
4. In the Investigator's judgment, a life expectancy of at least three (3)
months.
5.In the Investigator's judgement, patients should not be expected to
need corticosteroids during the 8 week assessment period.
6. At least 2 weeks since the last previous cancer treatment including:
chemotherapy, radiation therapy, immunotherapy, surgery, hormonal
therapy, or targeted biologics and 4 weeks for patients who received
treatment immediately prior to the study with anti-IL-1 or anti-TNF
agents.
7. For those subjects who have previously received treatment for cancer
related fatigue with agents such as corticosteroids or stimulants, a 2
week washout period is required from the last dose to C1D1.
8. Age =18, male or female subjects.
9. Serum potassium and magnesium levels within central laboratory
normal limits. Total serum calcium or ionized calcium level must be
greater than or equal to the lower limit of normal. Subjects with low
potassium, calcium and magnesium levels may be replenished to allow
for protocol entry.
10. Adequate renal function, defined by serum creatinine = 1.5 x ULN.
11. Adequate hepatic function defined as:
- total bilirubin = 1.5 times the central lab ULN.
- alanine aminotransferase (ALT) = 2.0 times the central lab ULN.
Exception: subjects with known liver metastases: = 3.0 times the central
lab ULN for ALT.
12. Adequate bone marrow function as defined as:
- absolute neutrophil count (neutrophil and bands) of ? 1,500/mm3 (?
1.5 x 109/L)
- platelet count between 150,000/mm3 and 450,000/mm3
- hemoglobin of = 9 g/dL
13. For women of childbearing potential (WOCBP), a negative serum
pregnancy test result at Screening.
14. Signed and dated institutional review board (IRB)/ Ethics Committee
(EC)-approved informed consent before any protocol-specific screening
procedures are performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 201
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 134

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 NYHCII.
- 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 hepatitis C antibody or
known history of infection.
10. History of tuberculosis (latent or active) or positive Interferongamma
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified