Recommended Dose Estimation of BP-C2 in Patients With Prostate Cancer: A Phase I Dose-finding Study.

PrCa-BPC2/I

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.

2023-04-01

2024-08-01

2024-09-30

Recruiting

Early phase I

8

Inclusion Criteria: * Prostate cancer patients between 18 and 80 years of age under hormonal treatment Exclusion Criteria: * 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. * Under radiological therapy * Under systemic treatment with corticosteroids or other immunosuppressive drugs the last 3 weeks before start of the trial treatment. * Participating in another clinical trial with pharmaceuticals the last six weeks before start of this trial treatment. * Not able to understand information. * Do not want or not able to give written consent to participate in the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Within-patient, 3-level Response Surface Pathway (RSP) design', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ESTIMATED'}}

2024-05-22