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Trial record 1 of 1 for:    NCT03274778
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Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

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ClinicalTrials.gov Identifier: NCT03274778
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea Alimonti, Oncology Institute of Southern Switzerland

Brief Summary:

Ruxolitinib will be dispensed to patients candidate to prostatectomy immediately after histological diagnosis of prostate adenocarcinoma. The treatment will be given for 28 days followed by a prostatectomy thereafter.

Tumor material and blood samples will be analysed before, during and after the treatment with Ruxolitinib.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ruxolitinib 20 MG Not Applicable

Detailed Description:

Patients with suspected localized prostate cancer will undergo biopsies spotting different prostate sites, as per standard clinical practice. Patients with histologically confirmed prostate adenocarcinoma and candidate for prostatectomy, after signing the Informed Consent Form, will receive Ruxolitinib for 4 weeks (the time normally elapsing between histological diagnosis and surgery) and will thereafter undergo prostatectomy.

Remaining biological material from the diagnosis and the prostatectomy will be sent to the Molecular Oncology Laboratory for molecular analysis.

In addition, blood samples will be drawn before, during Ruxolitinib treatment (Week 2), at the end of treatment (Week 4), and after prostatectomy (Week 5), to assess the frequency and subtype of immune subsets and the circulating levels of cytokines and secreted.

Patients will be monitored for occurrence of adverse events/surgical complications during treatment and up to 4 weeks after the intervention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory proof-of Mechanism Study to Assess the Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells and Additional Immune Subsets in Prostate Cancer Patients
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ruxolitinib
Oral administration of Ruxolitinib 20mg BID for 28 consecutive days
Drug: Ruxolitinib 20 MG
tablets
Other Name: Jakavi




Primary Outcome Measures :
  1. Tumor immune response [ Time Frame: 9 wks ]
    Tumor immune response modification induced by Ruxolitinib


Secondary Outcome Measures :
  1. pSTAT3 [ Time Frame: 5 wks ]
    Decrease of pSTAT3

  2. Cytokines [ Time Frame: 6 wks ]
    Reduction of cytokines associated to myeloid cells recruitment and tumor-promoting factors (e.g. IL8, IL6, TGF)

  3. KI-67 [ Time Frame: 9 wks ]
    Reduction by 50% of KI-67

  4. biomarkers [ Time Frame: 5 wks ]
    Increase of senescence and apoptosis markers (p16, p21, Beta-galactosidase, Caspase-3, Caspase-8)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70 years
  • Histological diagnosis of prostate adenocarcinoma
  • Stage ≥T2b for which surgery is indicated
  • No distant metastasis (M0)
  • NLR ≥3 in the blood or NLR ≥3 in the tumor biopsies or a percentage of MDSCs ≥ 30% in the tumour biopsies
  • PS (ECOG scale) 0-1
  • Adequate hepatic function: ALT and ASAT ≤ 2.5 x ULN, Bilirubin ≤ 1.5 ULN (exception if Gilbert's syndrome ≤ 2.5 x ULN)
  • Adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of Cockcroft-Gault
  • Hemoglobin ≥ 10 g/dl, leukocyte count ≥ 4.0 x 103/µl, platelet count ≥ 200 x 103/µl
  • Informed Consent as documented by the patient's signature

Exclusion Criteria:

  • No history of coagulation disorders and normal INR
  • Significant cardiovascular disorders in the last 12 months
  • Other clinically significant concomitant disease states which in the opinion of the Investigator may represent contraindications to study participation
  • Known or suspected non-compliance
  • Participation in another study with investigational drug within the 30 days preceding and during the present study
  • Ongoing treatment with strong CYP3A4 inhibitors or dual CYP2C9 and CYP3A4 inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274778


Contacts
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Contact: Andrea Alimonti, Prof. +41 (0)91 821 00 80 andrea.alimonti@ior.iosi.ch
Contact: Ricardo Pereira Mestre, Dr. med. +41 (0)91 811 84 46 Ricardo.PereiraMestre@eoc.ch

Locations
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Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI) Recruiting
Bellinzona, Switzerland, 6500
Contact: Ricardo Pereira Mestre, Dr. med.    +41 (0)91 811 84 46    Ricardo.PereiraMestre@eoc.ch   
Contact: Barbara Marongiu    +41 (0)91 811 91 20    barbara.marongiu@eoc.ch   
Sponsors and Collaborators
Oncology Institute of Southern Switzerland
Investigators
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Study Director: Andrea Alimonti, Prof. Institute of Oncology Research (IOR)

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Responsible Party: Andrea Alimonti, Prof. dr. med., Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier: NCT03274778     History of Changes
Other Study ID Numbers: IOSI-IOR-001
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases