Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04186585 |
Other study ID # |
PrCa-BPC2/I |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
April 1, 2023 |
Est. completion date |
September 30, 2024 |
Study information
Verified date |
May 2024 |
Source |
Meddoc |
Contact |
Stig Larsen, Phd |
Phone |
+47 41326325 |
Email |
stig.larsen[@]nmbu.no |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim is to estimate an oral administered recommended dose of BP-C2 in addition to hormone
treatment of prostate cancer.
The study population consists of prostatic cancer patients between 18 and 80 years of age
undergoing hormonal treatment. Four patients will be recruited consecutively from each of two
participating hospital.
The study will be performed as an open, one-dimensional multi-center trial with a 3-level
within-patient Response Surface Pathway (RSP) design.
Description:
Patients who seem to fulfil the inclusion without the exclusion criteria for the study will
enter a screening phase of seven days. During this period, a clinical investigation will be
performed, blood sample collected and prostate specific antigen (PSA) measured. The Common
Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and
classifying the tolerability and toxicity. Additionally, the quality of life (QoL)
questionnaires EQ-5D-5L developed by EuroQol will be used. Both CTCAE and QoL will be
recorded initially as individual baseline values. The trial treatment will start at the end
of the screening period, denoted as Day 0, and the patients receiving study identification
numbers.
BP-C2 will be administered orally once per day and the dose-window set to 0.33 - 1.67 mg/kg
body weight (bw). For an average patient of 75 kg this represents 5 - 25 ml. The starting
dose will be 1.0 mg/kg bw representing 15 ml for an average patient. All the eight
participating patients will receive the daily starting dose of 1.0 mg/kg bw for four weeks at
the first design-level. The study consists of three design-levels, each of four weeks
duration. CTCAE and QoL registration will be performed after two and four weeks at each
design-level. In case of life threatening, serious adverse events, or occurrence of
unacceptable side effects related to the trial substance, the treatment will be stopped.
The CTCAE results are shown in the two variables "Sum CTCAE score" and "Max CTCAE". The
tolerability classification used in the study design is based on the Max score as: "0=none",
"1=mild", "2= moderate", "3= severe", "4= Life threatening" and "5= death". The change in the
Max score from the study baseline to four weeks of BP-C2 treatment [4 weeks - baseline] are
classified as "0= unchanged or reduced", "1=small increase", "2= moderate increase", "3=
severe increase" and "4= life-threatening increase". In case the change in the Max score is
classified as 0 or 1, the dose to be used for the patient at the next design level will be
increased. If the change is 2 or 3, the dose will be reduced. Termination of the study occurs
if the change in the Max score is 4 or larger. The size of the dose escalation or
de-escalation will be calculated in accordance with the Response Surface Pathway (RSP)
procedure depending on the change in Max CTCAE score from baseline to the end of each
design-level. Based on the results obtained after four weeks of treatment at one design
level, the dose to be used at the next design level will be individually calculated.
Each patient will be followed up four weeks after end of treatment with final CTCAE and QoL
registration.
The CTCAE related variables are the main variables in this study. The secondary variables are
the QoL variables EQ index and EQ-VAS.