drugset / Trial / NCT04186585
Recommended Dose Estimation of BP-C2
Non-randomizedSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2023-04-01
- Primary completion
- 2025-08-01
- Completion
- 2025-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BP-C2 | Other / unclassified | 1 mg/kg | Oral |