JOURNAL ONKOLOGIE – STUDIE

MDPK67b in Patients With Prostate Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05580107

Studienbeginn:
August 2021

Letztes Update:
07.11.2023

Wirkstoff:
MDPK67b

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Med Discovery SA

Collaborator:
Camara and Partners Sàrl, Soladis,

Studienleiter

Daniel Eberli, Prof.
Principal Investigator
Klinik für Urologie, UniversitätSpital Zürich (USZ)

Kontakt

Christoph Kündig
Kontakt:
Phone: +41 21 566 14 11
E-Mail: christoph.kundig@med-discovery.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Klinik für Urologie, UniversitätSpital Zürich (USZ)
8091 Zürich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Daniel Eberli, Prof.
Phone: +41 44 255 9619
E-Mail: daniel.eberli@usz.ch» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Tolerability and Safety (Time Frame - Day 1):
Number of subjects with changes in blood pressure

2. Tolerability and Safety (Time Frame - Day 8):
Number of subjects with changes in blood pressure

3. Tolerability and Safety (Time Frame - Day 15):
Number of subjects with changes in blood pressure

4. Tolerability and Safety (Time Frame - Day 20-25):
Number of subjects with changes in blood pressure

5. Tolerability and Safety (Time Frame - Day 1):
Body temperature

6. Tolerability and Safety (Time Frame - Day 8):
Number of subjects with changes in body temperature

7. Tolerability and Safety (Time Frame - Day 15):
Number of subjects with changes in body temperature

8. Tolerability and Safety (Time Frame - Day 20-25):
Number of subjects with changes in body temperature

9. Tolerability and Safety (Time Frame - Day 1):
Number of subjects with changes in respiration rate

10. Tolerability and Safety (Time Frame - Day 8):
Number of subjects with changes in respiration rate

11. Tolerability and Safety (Time Frame - Day 15):
Number of subjects with changes in respiration rate

12. Tolerability and Safety (Time Frame - Day 20-25):
Number of subjects with changes in respiration rate

13. Tolerability and Safety (Time Frame - Day 1):
Number of subjects with changes in weight

14. Tolerability and Safety (Time Frame - Day 8):
Number of subjects with changes in weight

15. Tolerability and Safety (Time Frame - Day 15):
Number of subjects with changes in weight

16. Tolerability and Safety (Time Frame - Day 20-25):
Number of subjects with changes in weight

17. Tolerability and Safety (Time Frame - Day 1):
Number of subjects with changes in QTc on ECG

18. Tolerability and Safety (Time Frame - Day 8):
Number of subjects with changes in QTc on ECG

19. Tolerability and Safety (Time Frame - Day 15):
Number of subjects with changes in QTc on ECG

20. Tolerability and Safety (Time Frame - Day 20-25):
Number of subjects with changes in QTc on ECG

21. Tolerability and Safety (Time Frame - Day 1):
Number of subjects with changes in heart rate on ECG

22. Tolerability and Safety (Time Frame - Day 8):
Number of subjects with changes in heart rate on ECG

23. Tolerability and Safety (Time Frame - Day 15):
Number of subjects with changes in heart rate on ECG

24. Tolerability and Safety (Time Frame - Day 20-25):
Number of subjects with changes in heart rate on ECG

25. Tolerability and Safety (Time Frame - Day 8):
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

26. Tolerability and Safety (Time Frame - Day 15):
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

27. Tolerability and Safety (Time Frame - Day 20-25):
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

28. Tolerability and Safety (Time Frame - Day 8):
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

29. Tolerability and Safety (Time Frame - Day 15):
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

30. Tolerability and Safety (Time Frame - Day 20-25):
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

31. Tolerability and Safety (Time Frame - Day 8):
Number of subjects with changes in urine safety parameters: pH, ketones, protein, glucose, blood, leukocytes, urobilinogen, bilirubin

32. Tolerability and Safety (Time Frame - Day 15):
Number of subjects with changes in urine safety parameters: pH, ketones, protein, glucose, blood, leukocytes, urobilinogen, bilirubin

33. Tolerability and Safety (Time Frame - Day 20-25):
Number of subjects with changes in urine safety parameters: pH, ketones, protein, glucose, blood, leukocytes, urobilinogen, bilirubin

34. Tolerability and Safety (Time Frame - Day 1):
Number of subjects with changes in physical examination

35. Tolerability and Safety (Time Frame - Day 8):
Number of subjects with changes in physical examination

36. Tolerability and Safety (Time Frame - Day 15):
Number of subjects with changes in physical examination

37. Tolerability and Safety (Time Frame - Day 20-25):
Number of subjects with changes in physical examination

38. Tolerability and Safety (Time Frame - Day 1):
Adverse events

39. Tolerability and Safety (Time Frame - Day 8):
Adverse events

40. Tolerability and Safety (Time Frame - Day 15):
Adverse events

41. Tolerability and Safety (Time Frame - Day 20-25):
Adverse events

42. Tolerability and Safety (Time Frame - Day 1):
Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)

43. Tolerability and Safety (Time Frame - Day 8):
Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)

44. Tolerability and Safety (Time Frame - Day 15):
Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)

Secondary outcome:

1. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Screening (Diagnostic biopsy)):
Androgen receptor expression

2. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Day 16/17 (Radical prostatectomy sample)):
Androgen receptor expression

3. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Screening (Diagnostic biopsy)):
Extent of proliferation using Ki67

4. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Day 16/17 (Radical prostatectomy sample)):
Extent of proliferation using Ki67

5. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Screening (Diagnostic biopsy)):
Extent of inflammation using leukocyte markers

6. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Day 16/17 (Radical prostatectomy sample)):
Extent of inflammation using leukocyte markers

7. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Screening (Diagnostic biopsy)):
Expression of KLK2, KLK4, and KLK14 using immunohistochemistry

8. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Day 16/17 (Radical prostatectomy sample)):
Expression of KLK2, KLK4, and KLK14 using immunohistochemistry

9. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Screening (Diagnostic biopsy)):
Treatment induced change in RNA transcriptome assessed by RNA sequencing

10. Histo-pathological and molecular changes in prostate tumor tissue samples (Time Frame - Day 16/17 (Radical prostatectomy sample)):
Treatment induced change in RNA transcriptome assessed by RNA sequencing

Geprüfte Regime

MDPK67b:
24 mg or 48 mg

Quelle: ClinicalTrials.gov

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