Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

• Status: Withdrawn
• Trial end date: 2020-03-24
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncology Institute of Southern Switzerland

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