NCT04186585 Recommended Dose Estimation of BP-C2
| NCT ID | NCT04186585 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Meddoc |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2023-04-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Svein Aa Ingelholm, PhD
STUDY CHAIR
Meabco A/S
Frequently Asked Questions
Who can join the NCT04186585 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04186585 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04186585 currently recruiting?
Yes, NCT04186585 is actively recruiting participants. Contact the research team at stig.larsen@nmbu.no for enrollment information.
Where is the NCT04186585 trial being conducted?
This trial is being conducted at Skjetten, Norway.
Who is sponsoring the NCT04186585 clinical trial?
NCT04186585 is sponsored by Meddoc. The principal investigator is Svein Aa Ingelholm, PhD at Meabco A/S. The trial plans to enroll 8 participants.
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