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OncoMatch/Clinical Trials/NCT04186585

Recommended Dose Estimation of BP-C2

Is NCT04186585 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BP-C2 for prostate cancer.

Phase 1RecruitingMeddocNCT04186585Data as of May 2026

Treatment: BP-C2The 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Prior therapy

Must have received: hormonal therapy

under hormonal treatment

Lab requirements

Kidney function

serum creatinine ≤120 µmol/l

Liver function

total bilirubin ≤34 µmol/l and ALAT ≤3x ULN (≤5x ULN if liver metastases)

Cardiac function

No clinically significant abnormal ECG

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. Clinically significant abnormal ECG.

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