Recommended Dose Estimation of BP-C2

NCT04186585 | Recruiting Phase 1 DMC

• 1 other identifier: PrCa-BPC2/I
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

BP-C2; Dose respons; Prostate Cancer; Hormon terapy

Outcome Measures

Primary Outcomes (10)

• Max CTCAE

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 0

• Max CTCAE

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 2

• Max CTCAE

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 4

• Max CTCAE

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 6

• Max CTCAE

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 8

• Sum CTCAE score

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 0

• Sum CTCAE score

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 2

• Sum CTCAE score

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 4

• Sum CTCAE score

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 6

• Sum CTCAE score

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Week 8

Secondary Outcomes (6)

• Quality of Life questionnaire (EQ-5D-5L)

  Week 0

• Quality of Life questionnaire (EQ-5D-5L)

  Week 4

• Quality of Life questionnaire (EQ-5D-5L)

  Week 8

• PSA

  Week 0

• PSA

  Week 4

Study Arms (3)

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

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

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

Drug: BP-C2

Interventions

BP-C2 DRUG

Oral daily intake

Also known as: Ammonium molybdate complexed with a lignin-derived polymer containing benzene polycarboxylic acids

First design level; Second design level; Third design level

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only men due to the diagnos
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate cancer patients between 18 and 80 years of age under hormonal treatment

You may not qualify if:

• Patients with expected survival time below 3 months
• 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.

Sponsors & Collaborators

• Meddoc: lead
• Meabco A/S: collaborator

Study Sites (1)

Meddoc

Skjetten, Akershus, 2013, Norway

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Svein Aa Ingelholm, PhD

  Meabco A/S

  STUDY CHAIR

Central Study Contacts

Stig Larsen, Phd

CONTACT

+47 41326325; stig.larsen@nmbu.no

Henning Arboe, MSc

CONTACT

+45 31137069; Henning.arboe@meabco.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Within-patient, 3-level Response Surface Pathway (RSP) design

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: April 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: September 30, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)