MDPK67b in Patients With Prostate Cancer

Med Discovery SA15 enrolled

Overview

Administration of MDPK67b to assess its Tolerability and Safety profile in prostate cancer patients, and to assess histo-pathological and molecular changes in prostate tumor tissue samples.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

MDPK67bDRUG

24 mg or 48 mg

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Subject screening criteria 1. Patients aged 18 years or older. 2. Patients who have untreated suspected PCa or PCa under active surveillance (AS) with progression/upgrading. 3. Patients who signed a written screening phase ICF. Subject non-screening criteria 1. Patients who have an uncontrolled disease that would unduly increase the risk of toxicity or limit compliance with study requirements in the opinion of the Investigator; including but not limited to: ongoing or active symptomatic infection, uncontrolled diabetes mellitus, diseases of the coagulation system, unstable or uncompensated cardiac, hepatic, renal, respiratory, or psychiatric disease. 2. Patients who required a significant change in their concomitant medications during the week prior to screening visit, or who will likely need to have a change in their concomitant medications during the study. This includes any medication other than those required for PCa diagnosis or for RPE. 3. Patients who have received prior radiotherapy to the prostate. 4. Patients who have had prior exposure to MDPK67b. 5. Patients who have participated in another clinical trial within 3 months prior to screening visit, except if in the opinion of the investigator the type of trial does not interfere in any way with the present trial (eg. non-interventional observational trial). In case of doubt, the sponsor's prior approval must be obtained and the decision to include such a patient will be documented in detail. Non-screening criteria are exclusion criteria for the screening phase. For the patients not participating in the screening phase (ie patients with previously established PCa diagnosis), all the criteria above shall be checked prior to enrolment in the treatment phase. However, these patients do not have to sign a screening ICF (screening criterion n°3 is not applicable), and for non-screening criterion n°5, the 3-month wash-out period is prior to the inclusion visit in the treatment phase. Subject inclusion criteria 1. Patients who still meet all the eligibility criteria checked at screening visit. 2. Patients who have untreated PCa with a Gleason score of 7 (preferably) or higher, with local disease or with metastatic disease (if metastatic, no visceral metastases, no more than five bone or lymph node metastases), and are scheduled to undergo RPE about 3 weeks later. 3. Patients with an expected minimal survival time of 12 months. 4. Patients who have an acceptable organ and marrow function as assessed at the inclusion visit and defined as follows: 1. Absolute neutrophil count ≥ 1.5 × 109/L. 2. Platelets ≥ 100 × 109/L. 3. Hemoglobin ≥ 9 g/dL. 4. Total bilirubin ≤ 1.5 × ULN, unless the patient has known Gilbert's syndrome. 5. Aspartate amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN in presence of liver metastasis. 6. Serum creatinine ≤ 2.0 × ULN, or GFR ≥ 30 mL/min by Cockcroft-Gault. 7. INR \<1.5, aPTT \< 60 s 5. Patients with an ECOG performance status ≤ 1. 6. Patients who agree to refrain to donate sperm for the duration of the study. 7. Patients who signed a written treatment phase ICF.

Locations (1)

Klinik für Urologie, UniversitätSpital Zürich (USZ)

Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Tolerability and Safety

Number of subjects with changes in blood pressure

Time frame: Day 1

Tolerability and Safety

Number of subjects with changes in blood pressure

Time frame: Day 8

Tolerability and Safety

Number of subjects with changes in blood pressure

Time frame: Day 15

Tolerability and Safety

Number of subjects with changes in blood pressure

Time frame: Day 20-25

Tolerability and Safety

Body temperature

Time frame: Day 1

Tolerability and Safety

Number of subjects with changes in body temperature

Time frame: Day 8

Tolerability and Safety

Number of subjects with changes in body temperature

Time frame: Day 15

Tolerability and Safety

Number of subjects with changes in body temperature

Time frame: Day 20-25

Tolerability and Safety

Number of subjects with changes in respiration rate

Time frame: Day 1

Tolerability and Safety

Number of subjects with changes in respiration rate

Central Contacts

Christoph Kündig

CONTACT

+41 21 566 14 11 christoph.kundig@med-discovery.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Tolerability and Safety

Number of subjects with changes in respiration rate

Time frame: Day 15

Tolerability and Safety

Number of subjects with changes in respiration rate

Time frame: Day 20-25

Tolerability and Safety

Number of subjects with changes in weight

Time frame: Day 1

Tolerability and Safety

Number of subjects with changes in weight

Time frame: Day 8

Tolerability and Safety

Number of subjects with changes in weight

Time frame: Day 15

Tolerability and Safety

Number of subjects with changes in weight

Time frame: Day 20-25

Tolerability and Safety

Number of subjects with changes in QTc on ECG

Time frame: Day 1

Tolerability and Safety

Number of subjects with changes in QTc on ECG

Time frame: Day 8

Tolerability and Safety

Number of subjects with changes in QTc on ECG

Time frame: Day 15

Tolerability and Safety

Number of subjects with changes in QTc on ECG

Time frame: Day 20-25

Tolerability and Safety

Number of subjects with changes in heart rate on ECG

Time frame: Day 1

Tolerability and Safety

Number of subjects with changes in heart rate on ECG

Time frame: Day 8

Tolerability and Safety

Number of subjects with changes in heart rate on ECG

Time frame: Day 15

Tolerability and Safety

Number of subjects with changes in heart rate on ECG

Time frame: Day 20-25

Tolerability and Safety

Number of subjects with changes in hematology safety parameters: haemoglobin, haematocrit, RBC, MCH, MCV, WBC differential count (absolute and relative count), platelet count, INR, aPTT, Thrombin time and fibrinogen

Time frame: Day 8

Tolerability and Safety

Time frame: Day 15

Tolerability and Safety

Time frame: Day 20-25

Tolerability and Safety

Number of subjects with changes in blood chemistry safety parameters: fasting glucose, total protein, creatinine, urea, sodium, potassium, calcium, uric acid, AST, ALT, CPK, AlkP, LDH, total bilirubin, PSA

Time frame: Day 8

Tolerability and Safety

Time frame: Day 15

Tolerability and Safety

Time frame: Day 20-25

Tolerability and Safety

Number of subjects with changes in urine safety parameters: pH, ketones, protein, glucose, blood, leukocytes, urobilinogen, bilirubin

Time frame: Day 8

Tolerability and Safety

Number of subjects with changes in urine safety parameters: pH, ketones, protein, glucose, blood, leukocytes, urobilinogen, bilirubin

Time frame: Day 15

Tolerability and Safety

Number of subjects with changes in urine safety parameters: pH, ketones, protein, glucose, blood, leukocytes, urobilinogen, bilirubin

Time frame: Day 20-25

Tolerability and Safety

Number of subjects with changes in physical examination

Time frame: Day 1

Tolerability and Safety

Number of subjects with changes in physical examination

Time frame: Day 8

Tolerability and Safety

Number of subjects with changes in physical examination

Time frame: Day 15

Tolerability and Safety

Number of subjects with changes in physical examination

Time frame: Day 20-25

Tolerability and Safety

Adverse events

Time frame: Day 1

Tolerability and Safety

Adverse events

Time frame: Day 8

Tolerability and Safety

Adverse events

Time frame: Day 15

Tolerability and Safety

Adverse events

Time frame: Day 20-25

Tolerability and Safety

Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)

Time frame: Day 1

Tolerability and Safety

Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)

Time frame: Day 8

Tolerability and Safety

Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)

Time frame: Day 15