Testing a dose of BP-C2 alongside hormone treatment for prostate cancer
Tests an oral dose of BP-C2 with hormone treatment in men with prostate cancer.
Key facts
- Who runs it
- Meddoc
- Where
- Skjetten, NorwaySee the site
- Trial code
- Registry title
- Recommended Dose Estimation of BP-C2
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 8 people, planned
- Started
- 1 Apr 2023
- Planned end
- 30 Sept 2025
- Type of study
- Interventional, 3 groups
- Treatments tested
- BP-C2
- Record updated
- 9 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men aged 18 to 80 with prostate cancer who are already having hormone treatment. It tests an oral dose of BP-C2 added to that treatment.
- Age
- 18 to 80 years
- Sex
- Men only
- Disease stage
- Prostate cancer. The record does not name a stage.
- Earlier treatment
- Must be having hormone treatment now. Cannot be having radiotherapy now. Cannot have taken corticosteroids or other immunosuppressive drugs in the last 3 weeks. Cannot have been in another drug trial in the last six weeks.
Main reasons for not taking part
- Expected survival below 3 months
- Abnormal liver function (total bilirubin >34 µmol/l or ALAT >3 times the upper normal range)
- Abnormal kidney function (serum creatinine >120 µmol/l (1.36 mg/dL))
- Proven cancer spread to the brain
- Another cancer at the same time, except non-melanoma skin cancer and early cervical cancer
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Prostate cancer patients between 18 and 80 years of age under hormonal treatment
Who cannot take part
- 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
- Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer
- 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 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Norway
- MeddocSkjetten, NorwayContact: Stig Larsen, PhDTaking people
About the trial
What the trial wants to find out
The aim is to estimate an oral administered recommended dose of BP-C2 in addition to hormone treatment of prostate cancer.
Read full original descriptionShow less
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.
The 3 groups in the trial
- First design levelTreatment being tested
All the 8 patients receives a daily oral dose of BP-C2 in ml equals the body weight divided by 5 for 4 weeks. This represents 15 ml for a patient of 75 kg
Treatment: BP-C2
- Second design levelTreatment being tested
Based on the results from the first design level, the daily BP-C2 dose will individually be increased by a factor of 1.4 or 1.2 in case of none or mild toxicity increase. If moderate or severe increase in toxicity is observed, the individual dose will be reduced by 0.8 or 0.6, respectively. Duration of the treatment is 4 weeks
Treatment: BP-C2
- Third design levelTreatment being tested
Based on the results from the second design level, the daily BP-C2 dose will individually be increased in case of none or mild toxicity increase and reduced if moderate or severe increase in toxicity is observed. Duration of the treatment is 4 weeks
Treatment: BP-C2
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Recommended Dose Estimation of BP-C2 in Patients With Prostate Cancer: A Phase I Dose-finding Study.
- Plain-language title
- Testing a dose of BP-C2 alongside hormone treatment for prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04186585, who can take part
- Record updated
- 9 May 2025