Metastatic Breast CancerPhase 1NCT04298333
Dose-finding Study of BP-C1 in Patients With Stage IV Breast Cancer
A Phase 1 study testing BP-C1 in people with Metastatic Breast Cancer and Stage IV Breast Cancer, run by Meabco A/S at 3 sites in 3 countries.
Trial summary
The purpose of this study is to estimate the cumulative Maximum Tolerated Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in the short-term treatment of metastatic breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Metastatic Breast Cancer, Stage IV Breast Cancer
- What is being tested?
- BP-C1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 27 Jun 2009to 4 Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with histologically verified metastatic breast cancer (stage IV) with measurable metastases, between 18 and 80 years of age, who had undergone at least three lines of chemotherapy and had an expected survival time of at least 3 months.
Who cannot join
- Patients fulfilling at least one of the following criteria will be excluded from participation in the study:
- Abnormal liver function classified as total bilirubin >34 μmol/L or ALAT > 3 times of the upper limit of normal (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5хULN.
- Abnormal kidney function defined by serum creatinine >120 μmol/L.
- Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10; INR >1.5.
- Verified metastases to the brain.
- Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
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- Abnormal haematology status defined by haemoglobin < 9.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3x10^9/L.
- Clinically significant abnormal ECG.
- Karnofsky performance status score <60%.
- Pregnant or breast feeding women.
- Women of fertile age who do not want to be tested for possible pregnancy.
- Fertile female who do not want to use safe protection against pregnancy, starting one month before the start of the study treatment and lasting at least six weeks after.
- Uncontrolled bacterial, viral, fungal or parasite infection.
- Under systemic treatment with corticosteroids or other immunosuppressive drugs in the last 21 days before start of the trial treatment.
- Participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment.
- Not able to understand information.
- Not willing or not able to give written consent to participate in the study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Estimation of Maximum Tolerable Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in Stage IV Breast Cancer Patients: A Phase I Dose-response Study
The purpose of this study is to estimate the cumulative Maximum Tolerated Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in the short-term treatment of metastatic breast cancer patients.
Read the detailed description
BP-C1, solution for injection 0.05%, is currently being developed for treatment of patients with metastatic breast cancer with palliative intent. Active substance of the product, which is a novel platinum-containing anticancer agent developed for intramuscular administration, is a cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin. The amphiphilic characteristics of the polymer have resulted in a product with clear and significantly altered and improved properties compared to other platinum analogues, e.g. cisplatin, carboplatin and oxaliplatin.
BP-C1 preserves antitumour activity of its predecessors (e.g. cisplatin and carboplatin), additionally offering the following advantages that ensure favourable outcome of treatment of metastatic breast cancer patients:
- injectable solution (intramuscular) does not cause injection site reactions;
- can be administered at home by a nurse or a patient;
- has an improved pharmacokinetic profile;
- demonstrates efficacy comparable to cisplatin and much higher than carboplatin (in-vitro; in-vivo data);
- exerts an additional immunomodulatory activity.
In this study BP-C1 will be administered as supportive care to patients with metastatic breast cancer (stage IV), who had undergone at least three lines of chemotherapy.
This study will be open-label, multi-centre with a sequential safety design based on 3-level between-patient Response Surface Pathway (RSP) algorithm. The eligible patients will be allocated to five independent sequences, with three patients in each sequence. The BP-C1 treatment period will be 32 days, the follow-up period will be 28 days after the last BP-C1 dose.
- Conditions
- Metastatic Breast Cancer, Stage IV Breast Cancer
- Being tested
- BP-C1
- Keywords
- BP-C1, Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin, Benzene polycarboxylic acids complex with cis-diammineplatinum(II), Metastatic Breast Cancer, Platinum analogue, Metronomic chemotherapy, Breast cancer, Cisplatin, Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP-C1Drug
Also called Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin, Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin
BP-C1, 0.05% solution for injection, will be administered intramuscularly once per day. The cumulative dose range will be 0.64-1.12 mg/kg body weight depending on design level (design level 1-3). The daily dose range will be 0.02-0.035 mg/kg body weight (0.04-0.07 mL/kg) depending on design level (design level 1-3).
Dose level 1: 0.02 mg/kg body weight (0.04 mL/kg) intramuscularly once daily for 32 consecutive days; dose level 2: 0.03 mg/kg body weight (0.06 mL/kg) intramuscularly once daily for 32 consecutive days; dose level 3: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days.
Changes in the cumulative dose of BP-C1 between patients in the sequence are predefined and will be adjusted by escalation/deescalation rules based on changes in toxicity observed in the previous design level.
The duration of BP-C1 treatment will be 32 days.
| Study group | Role | What they receive |
|---|---|---|
| BP-C1 | Experimental | BP-C1 will be used as supportive care Receives: Drug: BP-C1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Common Terminology Criteria (CTC) score for Adverse Events
Maximum CTC score will be recorded using CTC v2.0 given as the highest observed CTC score at a given visit. The CTC scores will be recorded using CTC v2.0 divided in 15 System Organ Classes
Measured: baseline to Day 32 of treatment and Day 28 of follow-up
Sum Common Terminology Criteria (CTC) score for Adverse Events
The Sum CTC score will be a sum of all registered CTC scores obtained at a given visit. The CTC scores will be recorded using CTC v2.0 divided in 15 System Organ Classes
Measured: baseline to Day 32 of treatment and Day 28 of follow-up
Secondary outcomes (3)
Number of registered Adverse Events (AEs)
Measured: baseline to Day 32 of treatment period and Day 28 of follow-up
Treatment Response
In accordance with RECIST v1.1 the treatment response will be classified as 'complete response', 'partial response', 'stable disease' or 'progressive disease': Complete response (CR): disappearance of all target lesions. Partial response (PR): at least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions.
Measured: baseline to Day 32 of treatment and Day 28 of follow-up
Proportion of patients with Disease Control Rate (DCR)
The DCR defined as patients classified as SD, PR, CR
Measured: baseline to Day 32 of treatment and Day 28 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start27 Jun 2009
- Primary completion4 Jan 2011
- Study completion4 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast 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
- Supportive care
- Intervention model
- Sequential
- Model description
- The study will be open-label, multi-center with a sequential safety design based on 3-level between-patient Response Surface Pathway (RSP) algorithm. Three patients will be recruited consecutively to each sequence of three dose levels (dose level 1 - cumulative dose 0.64 mg/kg body weight, dose level 2 - cumulative dose 0.96 mg/kg body weight, dose level 3 - cumulative dose 1.12 mg/kg body weight).
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meabco A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meddoc, Norwegian University of Life Sciences, Meddoc Research Indonesia Ltd, Meddoc Research Taiwan Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298333
- Sponsor's protocol ID
- BMC2008-02
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Maximum Tolerable Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in Stage IV Breast Cancer Patients: A Phase I Dose-response Study
- ClinicalTrials.gov ID
- NCT04298333
- Acronym / sponsor ID
- BMC2008-02
- Conditions
- Metastatic Breast Cancer, Stage IV Breast Cancer
- Keywords
- BP-C1, Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin, Benzene polycarboxylic acids complex with cis-diammineplatinum(II), Metastatic Breast Cancer, Platinum analogue, Metronomic chemotherapy, Breast cancer, Cisplatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Meabco A/SIndustry (pharma, biotech, devices)
- Collaborators
- Meddoc, Norwegian University of Life Sciences, Meddoc Research Indonesia Ltd, Meddoc Research Taiwan Ltd
- Study start
- 27 Jun 2009 (actual)
- Primary completion
- 4 Jan 2011 (actual)
- Study completion
- 4 Jan 2011 (actual)
- First posted
- 6 Mar 2020 (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 purpose of this study is to estimate the cumulative Maximum Tolerated Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in the short-term treatment of metastatic breast cancer patients.
Detailed description
BP-C1, solution for injection 0.05%, is currently being developed for treatment of patients with metastatic breast cancer with palliative intent. Active substance of the product, which is a novel platinum-containing anticancer agent developed for intramuscular administration, is a cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin. The amphiphilic characteristics of the polymer have resulted in a product with clear and significantly altered and improved properties compared to other platinum analogues, e.g. cisplatin, carboplatin and oxaliplatin.
BP-C1 preserves antitumour activity of its predecessors (e.g. cisplatin and carboplatin), additionally offering the following advantages that ensure favourable outcome of treatment of metastatic breast cancer patients:
- injectable solution (intramuscular) does not cause injection site reactions;
- can be administered at home by a nurse or a patient;
- has an improved pharmacokinetic profile;
- demonstrates efficacy comparable to cisplatin and much higher than carboplatin (in-vitro; in-vivo data);
- exerts an additional immunomodulatory activity.
In this study BP-C1 will be administered as supportive care to patients with metastatic breast cancer (stage IV), who had undergone at least three lines of chemotherapy.
This study will be open-label, multi-centre with a sequential safety design based on 3-level between-patient Response Surface Pathway (RSP) algorithm. The eligible patients will be allocated to five independent sequences, with three patients in each sequence. The BP-C1 treatment period will be 32 days, the follow-up period will be 28 days after the last BP-C1 dose.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be open-label, multi-center with a sequential safety design based on 3-level between-patient Response Surface Pathway (RSP) algorithm. Three patients will be recruited consecutively to each sequence of three dose levels (dose level 1 - cumulative dose 0.64 mg/kg body weight, dose level 2 - cumulative dose 0.96 mg/kg body weight, dose level 3 - cumulative dose 1.12 mg/kg body weight).
| Arm | Type | Receives |
|---|---|---|
| BP-C1 | Experimental | Drug: BP-C1BP-C1 will be used as supportive care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients with histologically verified metastatic breast cancer (stage IV) with measurable metastases, between 18 and 80 years of age, who had undergone at least three lines of chemotherapy and had an expected survival time of at least 3 months.
Key exclusion criteria (17 listed)
- Patients fulfilling at least one of the following criteria will be excluded from participation in the study:
- Abnormal liver function classified as total bilirubin >34 μmol/L or ALAT > 3 times of the upper limit of normal (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5хULN.
- Abnormal kidney function defined by serum creatinine >120 μmol/L.
- Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10; INR >1.5.
- Verified metastases to the brain.
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-C1Also: Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin, Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from ligninBP-C1, 0.05% solution for injection, will be administered intramuscularly once per day. The cumulative dose range will be 0.64-1.12 mg/kg body weight depending on design level (design level 1-3). The daily dose range will be 0.02-0.035 mg/kg body weight (0.04-0.07 mL/kg) depending on design level (design level 1-3). Dose level 1: 0.02 mg/kg body weight (0.04 mL/kg) intramuscularly once daily for 32 consecutive days; dose level 2: 0.03 mg/kg body weight (0.06 mL/kg) intramuscularly once daily for 32 consecutive days; dose level 3: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days. Changes in the cumulative dose of BP-C1 between patients in the sequence are predefined and will be adjusted by escalation/deescalation rules based on changes in toxicity observed in the previous design level. The duration of BP-C1 treatment will be 32 days. | Drug | BP-C1 |
Primary outcome
Change in Maximum Common Terminology Criteria (CTC) score for Adverse Events
Time frame: baseline to Day 32 of treatment and Day 28 of follow-up
Maximum CTC score will be recorded using CTC v2.0 given as the highest observed CTC score at a given visit. The CTC scores will be recorded using CTC v2.0 divided in 15 System Organ Classes
Sum Common Terminology Criteria (CTC) score for Adverse Events
Time frame: baseline to Day 32 of treatment and Day 28 of follow-up
The Sum CTC score will be a sum of all registered CTC scores obtained at a given visit. The CTC scores will be recorded using CTC v2.0 divided in 15 System Organ Classes
3 secondary outcomes
Number of registered Adverse Events (AEs)
Time frame: baseline to Day 32 of treatment period and Day 28 of follow-up
Treatment Response
Time frame: baseline to Day 32 of treatment and Day 28 of follow-up
Proportion of patients with Disease Control Rate (DCR)
Time frame: baseline to Day 32 of treatment and Day 28 of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Benzene-Poly-Carboxylic Acids Complex with Cis-Diammineplatinum (II) Dichloride in the Treatment of Stage IV Breast Cancer PatientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BP-C1 in people with Metastatic Breast Cancer and Stage IV Breast Cancer, run by Meabco A/S at 3 sites in 3 countries.
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 17 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: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia, Taiwan, Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum Common Terminology Criteria (CTC) score for Adverse Events (time frame: baseline to Day 32 of treatment and Day 28 of follow-up). The study lists 2 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 6 Mar 2020.