NCT04186585
Recommended Dose Estimation of BP-C2
Recruiting · Phase 1 · Meddoc · registry updated 2025-05-09
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Prostate cancer patients between 18 and 80 years of age under hormonal treatment
Exclusion
- 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.
- Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
- Clinically significant abnormal ECG.