NCT04186585RecruitingPhase 1
Recommended Dose Estimation of BP-C2
Recommended Dose Estimation of BP-C2 in Patients With Prostate Cancer: A Phase I Dose-finding Study.
Source: ClinicalTrials.gov · Last updated 9 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 3 Dec 2019
- Start date
- 1 Apr 2023
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- Meddoc
- Diseases
- Prostate cancer
- NCT number
- NCT04186585
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 8
- From 1 Apr 2023 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
Lab values
- 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.
Other
- Patients with expected survival time below 3 months
- Patients with verified metastasis to the brain.
- Clinically significant abnormal ECG.
- Not able to understand information.
- Do not want or not able to give written consent to participate in the study.
Who the study is looking for
- Prostate cancer patients between 18 and 80 years of age under hormonal treatment
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Meddoc Coordinator of this site? Confirm its status | Skjetten | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.