Prostate CancerPhase 1NCT04186585
Recommended Dose Estimation of BP-C2
A Phase 1 study testing BP-C2 in people with Prostate Cancer, run by Meddoc at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- BP-C2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2023to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate cancer patients between 18 and 80 years of age under hormonal treatment
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Meddoc
Skjetten, Akershus, 2013
Stig Larsen, PhD, 41326325, sl@meddoc.no
Hans E Fagertun, MS, 92642970, hf@meddoc.no
About this study
Official title: Recommended Dose Estimation of BP-C2 in Patients With Prostate Cancer: A Phase I Dose-finding Study.
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.
Read the detailed description
Patients who seem to fulfil the inclusion without the exclusion criteria for the study will enter a screening phase of seven days. During this period, a clinical investigation will be performed, blood sample collected and prostate specific antigen (PSA) measured. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be used. Both CTCAE and QoL will be recorded initially as individual baseline values. The trial treatment will start at the end of the screening period, denoted as Day 0, and the patients receiving study identification numbers.
BP-C2 will be administered orally once per day and the dose-window set to 0.33 - 1.67 mg/kg body weight (bw). For an average patient of 75 kg this represents 5 - 25 ml. The starting dose will be 1.0 mg/kg bw representing 15 ml for an average patient. All the eight participating patients will receive the daily starting dose of 1.0 mg/kg bw for four weeks at the first design-level. The study consists of three design-levels, each of four weeks duration. CTCAE and QoL registration will be performed after two and four weeks at each design-level. In case of life threatening, serious adverse events, or occurrence of unacceptable side effects related to the trial substance, the treatment will be stopped.
The CTCAE results are shown in the two variables "Sum CTCAE score" and "Max CTCAE". The tolerability classification used in the study design is based on the Max score as: "0=none", "1=mild", "2= moderate", "3= severe", "4= Life threatening" and "5= death". The change in the Max score from the study baseline to four weeks of BP-C2 treatment [4 weeks - baseline] are classified as "0= unchanged or reduced", "1=small increase", "2= moderate increase", "3= severe increase" and "4= life-threatening increase". In case the change in the Max score is classified as 0 or 1, the dose to be used for the patient at the next design level will be increased. If the change is 2 or 3, the dose will be reduced. Termination of the study occurs if the change in the Max score is 4 or larger. The size of the dose escalation or de-escalation will be calculated in accordance with the Response Surface Pathway (RSP) procedure depending on the change in Max CTCAE score from baseline to the end of each design-level. Based on the results obtained after four weeks of treatment at one design level, the dose to be used at the next design level will be individually calculated.
Each patient will be followed up four weeks after end of treatment with final CTCAE and QoL registration.
The CTCAE related variables are the main variables in this study. The secondary variables are the QoL variables EQ index and EQ-VAS.
- Conditions
- Prostate Cancer
- Being tested
- BP-C2
- Keywords
- BP-C2, Dose respons, Prostate Cancer, Hormon terapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP-C2Drug
Also called Ammonium molybdate complexed with a lignin-derived polymer containing benzene polycarboxylic acids
Oral daily intake
| Study group | Role | What they receive |
|---|---|---|
| First design level | Experimental | 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 Receives: Drug: BP-C2 |
| Second design level | Experimental | 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 Receives: Drug: BP-C2 |
| Third design level | Experimental | 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 Receives: Drug: BP-C2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Max CTCAE
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 0
Max CTCAE
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 2
Max CTCAE
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 4
Max CTCAE
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 6
Max CTCAE
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 8
Sum CTCAE score
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 0
Sum CTCAE score
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 2
Sum CTCAE score
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 4
Sum CTCAE score
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 6
Sum CTCAE score
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Week 8
Secondary outcomes (6)
Quality of Life questionnaire (EQ-5D-5L)
Five score levels: "Mobility", "Self-care","Usual activity", "Pain/Discomfort", "Anxiety/Depression" and "Overall daily health situation"
Measured: Week 0
Quality of Life questionnaire (EQ-5D-5L)
Five score levels: "Mobility", "Self-care","Usual activity", "Pain/Discomfort", "Anxiety/Depression" and "Overall daily health situation"
Measured: Week 4
Quality of Life questionnaire (EQ-5D-5L)
Five score levels: "Mobility", "Self-care","Usual activity", "Pain/Discomfort", "Anxiety/Depression" and "Overall daily health situation"
Measured: Week 8
PSA
Prostate marker
Measured: Week 0
PSA
Prostate marker
Measured: Week 4
PSA
Prostate marker
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Apr 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Within-patient, 3-level Response Surface Pathway (RSP) design
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meddoc
- Sponsor type
- University, hospital or other
- Collaborators
- Meabco A/S
- Responsible party
- Principal investigator, Prof Stig Larsen, Meddoc
- Investigators
- Svein Aa Ingelholm, PhD, Study chair, Meabco A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186585
- Sponsor's protocol ID
- PrCa-BPC2/I
- Status last verified
- May 2025
- First submitted
- 3 Dec 2019
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be available for the study inverstigators, statistician and the data manager
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recommended Dose Estimation of BP-C2 in Patients With Prostate Cancer: A Phase I Dose-finding Study.
- ClinicalTrials.gov ID
- NCT04186585
- Acronym / sponsor ID
- PrCa-BPC2/I
- Conditions
- Prostate Cancer
- Keywords
- BP-C2, Dose respons, Prostate Cancer, Hormon terapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- MeddocUniversity, hospital or other
- Collaborators
- Meabco A/S
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who seem to fulfil the inclusion without the exclusion criteria for the study will enter a screening phase of seven days. During this period, a clinical investigation will be performed, blood sample collected and prostate specific antigen (PSA) measured. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be used. Both CTCAE and QoL will be recorded initially as individual baseline values. The trial treatment will start at the end of the screening period, denoted as Day 0, and the patients receiving study identification numbers.
BP-C2 will be administered orally once per day and the dose-window set to 0.33 - 1.67 mg/kg body weight (bw). For an average patient of 75 kg this represents 5 - 25 ml. The starting dose will be 1.0 mg/kg bw representing 15 ml for an average patient. All the eight participating patients will receive the daily starting dose of 1.0 mg/kg bw for four weeks at the first design-level. The study consists of three design-levels, each of four weeks duration. CTCAE and QoL registration will be performed after two and four weeks at each design-level. In case of life threatening, serious adverse events, or occurrence of unacceptable side effects related to the trial substance, the treatment will be stopped.
The CTCAE results are shown in the two variables "Sum CTCAE score" and "Max CTCAE". The tolerability classification used in the study design is based on the Max score as: "0=none", "1=mild", "2= moderate", "3= severe", "4= Life threatening" and "5= death". The change in the Max score from the study baseline to four weeks of BP-C2 treatment [4 weeks - baseline] are classified as "0= unchanged or reduced", "1=small increase", "2= moderate increase", "3= severe increase" and "4= life-threatening increase". In case the change in the Max score is classified as 0 or 1, the dose to be used for the patient at the next design level will be increased. If the change is 2 or 3, the dose will be reduced. Termination of the study occurs if the change in the Max score is 4 or larger. The size of the dose escalation or de-escalation will be calculated in accordance with the Response Surface Pathway (RSP) procedure depending on the change in Max CTCAE score from baseline to the end of each design-level. Based on the results obtained after four weeks of treatment at one design level, the dose to be used at the next design level will be individually calculated.
Each patient will be followed up four weeks after end of treatment with final CTCAE and QoL registration.
The CTCAE related variables are the main variables in this study. The secondary variables are the QoL variables EQ index and EQ-VAS.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Within-patient, 3-level Response Surface Pathway (RSP) design
| Arm | Type | Receives |
|---|---|---|
| First design level | Experimental | Drug: BP-C2All 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 |
| Second design level | Experimental | Drug: BP-C2Based 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 |
| Third design level | Experimental | Drug: BP-C2Based 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prostate cancer patients between 18 and 80 years of age under hormonal treatment
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP-C2Also: Ammonium molybdate complexed with a lignin-derived polymer containing benzene polycarboxylic acidsOral daily intake | Drug | First design level, Second design level, Third design level |
Primary outcome
Max CTCAE
Time frame: Week 0
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Max CTCAE
Time frame: Week 2
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Max CTCAE
Time frame: Week 4
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Max CTCAE
Time frame: Week 6
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Max CTCAE
Time frame: Week 8
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Sum CTCAE score
Time frame: Week 0
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Sum CTCAE score
Time frame: Week 2
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Sum CTCAE score
Time frame: Week 4
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Sum CTCAE score
Time frame: Week 6
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Sum CTCAE score
Time frame: Week 8
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
6 secondary outcomes
Quality of Life questionnaire (EQ-5D-5L)
Time frame: Week 0
Quality of Life questionnaire (EQ-5D-5L)
Time frame: Week 4
Quality of Life questionnaire (EQ-5D-5L)
Time frame: Week 8
PSA
Time frame: Week 0
PSA
Time frame: Week 4
PSA
Time frame: Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No. The data will be available for the study inverstigators, statistician and the data manager
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Svein Aa Ingelholm, PhD study chair
Meabco A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BP-C2 in people with Prostate Cancer, run by Meddoc at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stig Larsen, Phd (+47 41326325, stig.larsen@nmbu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Max CTCAE (time frame: Week 0). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.