Estimating the recommended dose of BP-C2 for prostate cancer treatment
Recommended Dose Estimation of BP-C2 in Patients With Prostate Cancer: A Phase I Dose-finding Study.
This study is testing the best daily dose of a new drug called BP-C2 for men with prostate cancer who are also receiving hormone therapy, to see how well they tolerate it and how it affects their quality of life.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Meddoc Academic / other |
| Locations | 1 site (Skjetten, Akershus) |
| Trial ID | NCT04186585 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal oral dose of BP-C2 in conjunction with hormone therapy for patients with prostate cancer. It involves a screening phase followed by a treatment phase where patients will receive BP-C2 daily for four weeks at varying doses. The study will assess tolerability and quality of life using established criteria and questionnaires. A total of eight patients will be recruited from two participating hospitals, and the trial will utilize a multi-center, open-label design.
Who should consider this trial
Good fit: Ideal candidates are prostate cancer patients aged 18 to 80 who are currently undergoing hormonal treatment.
Not a fit: Patients with severe liver or kidney dysfunction, brain metastases, or those participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective dosing regimen for BP-C2 that enhances treatment outcomes for prostate cancer patients.
How similar studies have performed: While this approach is novel in the context of BP-C2, similar studies have shown promise in optimizing dosing for cancer treatments.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Skjetten, Akershus
- Meddoc — Skjetten, Akershus, Norway (Recruiting)
Study contacts
- Study coordinator: Stig Larsen, Phd
- Email: stig.larsen@nmbu.no
- Phone: +47 41326325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.