Actively Recruiting
Recommended Dose Estimation of BP-C2
Led by Meddoc · Updated on 2025-05-09
8
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
M
Meddoc
Lead Sponsor
M
Meabco A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Recommended Dose Estimation of BP-C2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prostate cancer patients between 18 and 80 years of age under hormonal treatment
You will not qualify if you...
- Patients with expected survival time below 3 months
- Abnormal liver function classified as total bilirubin >34 �b5mol/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 �b5mol/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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Meddoc
Skjetten, Akershus, Norway, 2013
Actively Recruiting
Research Team
S
Stig Larsen, Phd
CONTACT
H
Henning Arboe, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
3
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