Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03274778
• Date of registration: 05/09/2017
• Prospective Registration: No
• Primary sponsor: Oncology Institute of Southern Switzerland
• Public title: Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells
• Scientific 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
• Date of first enrolment: September 1, 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03274778
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Andrea Alimonti, Prof.
• Affiliation: Institute of Oncology Research (IOR)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: Ruxolitinib 20 MG

Primary Outcome(s)

Tumor immune response [Time Frame: 9 wks]

Secondary Outcome(s)

KI-67 [Time Frame: 9 wks]

Cytokines [Time Frame: 6 wks]

biomarkers [Time Frame: 5 wks]

pSTAT3 [Time Frame: 5 wks]

Secondary ID(s)

IOSI-IOR-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors