Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to find the best dose of a new medication called BP-C2 that will be taken by mouth, for men with prostate cancer who are also receiving hormone treatment. The goal is to understand how much of the medication is safe and effective for patients. The study will include men aged 18 to 80 who are already undergoing hormone therapy for their prostate cancer. It will take place in two hospitals, and a total of eight patients will be included in the study.
To be eligible for this trial, patients must be men diagnosed with prostate cancer and currently receiving hormone treatment. However, those with certain health issues, like severe liver or kidney problems, brain metastasis (cancer spread to the brain), or those currently on specific treatments that could interfere with the study, will not be able to participate. Participants can expect to have their dose of BP-C2 adjusted during the study to find the most effective amount for their condition. It's important to note that all participants will need to understand the study details and provide written consent to take part. This trial is currently recruiting patients, aiming to contribute valuable insights into improving prostate cancer treatment.
Gender
MALE
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.
About Meddoc
meddoc is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a focus on improving patient outcomes, meddoc specializes in the development and management of clinical trials across various therapeutic areas. The organization leverages cutting-edge technology and a robust network of healthcare professionals to ensure the highest standards of safety and efficacy in its studies. Committed to ethical practices and regulatory compliance, meddoc strives to foster collaboration between researchers, clinicians, and patients, ultimately contributing to the acceleration of groundbreaking treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Skjetten, Akershus, Norway
Patients applied
Trial Officials
Svein Aa Ingelholm, PhD
Study Chair
Meabco A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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