Metastatic colorectal cancer patients.
Conditions
Interventions
Clinical safety/efficacy, randomized, double-blinded, phase 3 trial of placebo versus xilonix. It will be included 800 patients of both sexes aged 18 years or older. Patients will receive 1 dose every
Drug
Biological/vaccine
Sponsors
XBiotech USA Inc
Clinipace Pesquisas Clínicas do Brasil Ltda. - CPWW
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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 at least all of the following agents: oxaliplatin, irinotecan, flouropyrimidine, and cetuximab or panitumumab if KRAS (retrovirus-associated DNA (desoxinucleic acid) sequences isolated from Kirsten murine sarcoma viruses) wildtype; subjects will not be treated with any radiation, chemotherapy, or investigational agents while enrolled in this protocol; Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2; 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 (anti-interleukin 1) or anti-TNF (tumor necrosis factor) agents; age 18 years or older, male or female subjects; serum potassium and magnesium levels within Central Lab 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; adequate renal function; adequate hepatic function; adequate bone marrow function; for women of childbearing potential (WOCBP), a negative serum pregnancy test result at screening and monthly thereafter; for women who are not postmenopausal (24 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use adequate methods of contraception, during the treatment period and for at least 1 month after the last dose of study drug; signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed; patients enrolled must, in the investigator’s judgment, be healthy enough to stay on the clinical trial for three months.
Exclusion criteria
Exclusion criteria: Mechanical obstruction that would prevent adequate oral nutritional intake; serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy; uncontrolled or significant cardiovascular disease; dementia or altered mental status that would prohibit the understanding or rendering of informed consent; subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to grade equal or lower than 1, excluding alopecia and grade 2 neuropathy; immunocompromised subjects; history of hepatitis B or C; history of tuberculosis; receipt of a live (attenuated) vaccine within 1 month prior to screening; subjects with history of hypersensitivity to compounds of similar chemical or biologic composition of xilonix; women who are pregnant or breastfeeding; 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 1 month after the last dose of study medication; weight loss higher than 20% in the previous 6 months; history of progressive multifocal leukoencephalopathy or other demyelinating disease; subjects on immunosuppressive therapy, including transplant patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival will be the primary endpoint of this study survival time will be defined as the duration from the date of randomization until death or censor date. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include change in lean body mass (LBM) and quality of life from screening to the cycle 5 assessment. Other secondary endpoints will be progression-free survival, objective response rate (ORR), disease control rate (DCR), and stabilization of platelet counts. Lean body mass measurements will be obtained through the use of dual energy X-ray absorptiometry (DEXA) scans. Quality of life will be assessed with the EORTC QLQ-C30 version 3 (Quality of Life Questionnaire for Cancer patients from the European Organization for Research and Treatment of Cancer). Response and progression will be evaluated using the Immune Related Response Criteria (irRC). | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactHelena;Sandra Petridis;Schefler
Clinipace Pesquisas Clínicas do Brasil Ltda. - CPWW;Clinipace Pesquisas Clínicas do Brasil Ltda. - CPWW
Outcome results
None listed