Clinical trial for Prostate Cancer
Official title Recommended Dose Estimation of BP-C2
ClinicalTrials.gov ID: NCT04186585
What this study is testing
What is BP-C2?
BP-C2 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer.
Also referred to as Ammonium molybdate complexed with a lignin-derived polymer containing benzene polycarboxylic acids.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- Prostate cancer patients between 18 and 80 years of age under hormonal treatment
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Prostate cancer patients between 18 and 80 years of age under hormonal treatment
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Skjetten, Akershus, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Skjetten, Akershus, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.