Study of Ruxolitinib in the Treatment of Cachexia in Patients With Tumor-Associated Chronic Wasti… (NCT02072057) | Clinical Trial Compass
TerminatedPhase 2
Study of Ruxolitinib in the Treatment of Cachexia in Patients With Tumor-Associated Chronic Wasting Diseases.
Stopped: Poor recruiting
Switzerland8 participantsStarted 2014-04-20
Plain-language summary
The aim of this study is to investigate the effects and safety of Ruxolitinib, a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) inhibitor for the treatment of tumor-associated cachexia in chronic wasting diseases.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Definition of cachexia (see Section 11.1) fulfilled
* Age ≥ 18 years
* Confirmed tumor of any site
* Life expectancy of ≥3 months
* Subject must be willing to receive transfusion of blood products
* Patient must give written informed consent
* Females of childbearing potential (FCBP) must undergo pregnancy testing (serum) and pregnancy result must be negative.\*
* Reliable contraception should be maintained throughout the study and for 28 days after study treatment discontinuation
* Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods
* Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with FCBP. Males must agree not to donate semen or sperm
Exclusion Criteria:
* Pregnant or breast feeding females
* Lack of written informed consent
* No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
* No consent for "Translational Research" and "Biobanking" (see separate documents "Aufbewahrung und Weiterverwendung von biologischem Material und von Daten fĂĽr die biomedizinische Forschung" und "Biobankreglement" for the RUXexia Trial).
* Thrombocytopenia \< 50 x 10e9/l
* Peroral intake not possible, in particular by stenosis of the esophagus
* New started treatment of the tumor (first 3…