Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

NCT03274778 | Withdrawn

• 1 other identifier: IOSI-IOR-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor immune response

  Tumor immune response modification induced by Ruxolitinib

  9 wks

Secondary Outcomes (4)

• pSTAT3

  5 wks

• Cytokines

  6 wks

• KI-67

  9 wks

• biomarkers

  5 wks

Study Arms (1)

Ruxolitinib

EXPERIMENTAL

Oral administration of Ruxolitinib 20mg BID for 28 consecutive days

Drug: Ruxolitinib 20 MG

Interventions

Ruxolitinib 20 MG DRUG

tablets

Also known as: Jakavi

Ruxolitinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead

Study Sites (1)

Istituto Oncologico della Svizzera Italiana (IOSI)

Bellinzona, 6500, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrea Alimonti, Prof.

  Institute of Oncology Research (IOR)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 7, 2017
• Study Start: September 1, 2017
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: November 18, 2025

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)