Trial record 3 of 4 for:    Transmissible Spongiform Encephalopathies

Study of Ruxolitinib in the Treatment of Cachexia in Patients With Tumor-Associated Chronic Wasting Diseases.

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Kantonsspital Aarau
Sponsor:
Collaborators:
Clinical Trial Unit, University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
Novartis
Information provided by (Responsible Party):
Nathan Cantoni, Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT02072057
First received: February 21, 2014
Last updated: April 5, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Cancer Cachexia
Drug: Ruxolitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The RUXexia Trial: An Open-label Phase II Trial of Ruxolitinib in the Treatment of Cachexia in Patients With Tumor-Associated Chronic Wasting Diseases.

Resource links provided by NLM:


Further study details as provided by Kantonsspital Aarau:

Primary Outcome Measures:
  • Body weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight [ Time Frame: Baseline. 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months ] [ Designated as safety issue: No ]
  • Lean Body (muscle) Mass (LBM) [ Time Frame: Baseline. 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Dual energy X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA)

  • Resting energy expenditure (REE) [ Time Frame: Baseline. 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Indirect calorimetry

  • Activity Energy Expenditure (AEE) [ Time Frame: Baseline. 3, 6, and 12 months ] [ Designated as safety issue: No ]
    AEE-Questionnaires

  • Body mass index (BMI) [ Time Frame: Baseline. 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Formula BMI = W / H2 (W=body weight in kilograms; H=body height in meters)

  • Tumor assessment [ Time Frame: Baseline. 6, and 12 months ] [ Designated as safety issue: No ]
    Clinical and radiological (CT or MRI)

  • Grip Strength [ Time Frame: Baseline. 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Grip Strength measured by dynamometer

  • Quality of Life [ Time Frame: Baseline. 1, 2, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    EORTC-QLQ-C30 questionnaire

  • Nutritional history [ Time Frame: Baseline. After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months ] [ Designated as safety issue: No ]
    Nutritional Risk Screening Tool

  • Number of adverse events [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
    Reporting of adverse events according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  • Stair climbing test [ Time Frame: Baseline. 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Measurement of power and speed on a stair climbing test (Stair climb speed [m/sec]=[height of 12 steps(meters)]/[time (seconds) up the 12 steps]; Stair climb power [watts]=[9.8 m/sec2]*[weight (kg)]*[height of 12 steps(meters)]/[time (seconds) up the 12 steps]).


Other Outcome Measures:
  • Cytokines levels [ Time Frame: Baseline. 1, 2, 3, 4, 5, 6, and 12 months ] [ Designated as safety issue: No ]
    Multiplex-assays for proinflammatory cytokines

  • Reactive oxygen species (ROS) levels [ Time Frame: Baseline. 1, 2, 3, 4, 5, 6, and 12 months ] [ Designated as safety issue: No ]
    Free oxygen radical monitor (FORM) with proper kits (FORMOX with FORT and FORD analysis kits, Callegari 1930 S.P.A., Parma, Italy).

  • JAK/STAT pathway activation [ Time Frame: Baseline. 1, 2, 3, 4, 5, 6, and 12 months ] [ Designated as safety issue: No ]
    FACS analysis

  • microRNA [ Time Frame: Baseline. 12 Months ] [ Designated as safety issue: No ]
    PCR-assays for microRNA


Estimated Enrollment: 25
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib
Interventional arm
Drug: Ruxolitinib

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 für 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 months of a new treatment). Patients with a new treatment of the cancer disease should delay screening/enrollment until 3 months after start of this treatment.
  • Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
  • Patients with a Myeloproliferative Neoplasm
  • Patients receiving any "Prohibited Medications" (see protocol) within 7 days prior to the first dose of study drug
  • Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072057

Contacts
Contact: Isabel Pulvermüller, CRA +41 62 838 60 58 isabel.pulvermueller@ksa.ch
Contact: Therese Gurtner, CRA +41 62 838 60 58 therese.gurtner@ksa.ch

Locations
Switzerland
Division of Hematology/Oncolgy, University Clinic of Medicine, Kantonsspital Aarau AG Recruiting
Aarau, AG, Switzerland, 5001
Contact: Isabel Pulvermüller, CRA    +41 62 838 60 58    isabel.pulvermueller@ksa.ch   
Contact: Therese Gurtner, CRA    +41 62 838 60 58    therese.gurtner@ksa.ch   
Principal Investigator: Nathan Cantoni, MD         
Division of Hematology/Oncology, Kantonsspital Olten Not yet recruiting
Olten, SO, Switzerland, 4600
Contact: Isabel Pulvermüller, CRA    +41 62 838 60 58    isabel.pulvermueller@ksa.ch   
Contact: Therese Gurtner, CRA    +41 62 838 60 58    therese.gurtner@ksa.ch   
Principal Investigator: Walter Mingrone, MD         
Sponsors and Collaborators
Kantonsspital Aarau
Clinical Trial Unit, University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
Novartis
Investigators
Study Chair: Nathan Cantoni, MD Division of Hematology/Oncology, University Clinic of Medicine, Kantonsspital Aarau AG, CH-5001 Aarau, Switzerland
Study Chair: Mario Bargetzi, MD Division of Hematology/Oncology, University Clinic of Medicine, Kantonsspital Aarau AG, CH-5001 Aarau, Switzerland
  More Information

No publications provided

Responsible Party: Nathan Cantoni, MD, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT02072057     History of Changes
Other Study ID Numbers: ZOHTNC-02-2013
Study First Received: February 21, 2014
Last Updated: April 5, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Additional relevant MeSH terms:
Prion Diseases
Cachexia
Wasting Syndrome
Wasting Disease, Chronic
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 19, 2014