Recommended Dose Estimation of BP-C2

Overview

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.

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.

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