Recommended Dose Estimation of BP-C2
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-80
SponsorMeddoc
About this trial
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.
Eligibility criteria
Qualifiers
Prostate cancer patients between 18 and 80 years of age under hormonal treatment
Disqualifiers
Patients with expected survival time below 3 months
Abnormal liver function classified as total bilirubin >34 µmol/l or ALAT > 3 times the upper normal range (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5 x ULN.
Abnormal kidney function defined by serum creatinine >120 µmol/l.
Patients with verified metastasis to the brain.
Trial design
Treatments tested in this trial
- BP-C2
Treatment groups
8 Participants
are divided into 3 treatment groupsSponsors and collaborators
Meddoc
Lead sponsor
Meabco A/S
Collaborator
Source ClinicalTrials.gov