Recommended Dose Estimation of BP-C2 in Patients With Prostate Cancer: A Phase I Dose-finding Study.
Who is this study for? Patients with Prostate Cancer
What treatments are being studied? BP-C2
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Prostate cancer patients between 18 and 80 years of age under hormonal treatment
Locations
Other Locations
Norway
Meddoc
RECRUITING
Skjetten
Contact Information
Primary
Stig Larsen, Phd
stig.larsen@nmbu.no
+47 41326325
Backup
Henning Arboe, MSc
Henning.arboe@meabco.com
+45 31137069
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 8
Treatments
Experimental: First design level
All the 8 patients receives a daily oral dose of BP-C2 in ml equals the body weight divided by 5 for 4 weeks. This represents 15 ml for a patient of 75 kg
Experimental: Second design level
Based on the results from the first design level, the daily BP-C2 dose will individually be increased by a factor of 1.4 or 1.2 in case of none or mild toxicity increase. If moderate or severe increase in toxicity is observed, the individual dose will be reduced by 0.8 or 0.6, respectively. Duration of the treatment is 4 weeks
Experimental: Third design level
Based on the results from the second design level, the daily BP-C2 dose will individually be increased in case of none or mild toxicity increase and reduced if moderate or severe increase in toxicity is observed. Duration of the treatment is 4 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Meabco A/S
Leads: Meddoc