Metastatic Breast CancerPhase 2NCT03603197
BP-C1 in Short-term Treatment of Thai Patients With Metastatic Breast Cancer
A Phase 2 study testing BP-C1 in people with Metastatic Breast Cancer and Stage IV Breast Cancer, run by Meabco A/S at 4 sites in Thailand.
Trial summary
The purpose of this study is to determine whether BP-C1 is effective in the short-term treatment of metastatic breast cancer patients who have previously undergone at least three lines of chemotherapy. 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?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 4 sitesThailand
- Study dates
- 5 Jun 2014to 30 Aug 2016
- Phase
- Phase 2
- 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.
Show all 17Show fewer
- Abnormal hematology status defined by hemoglobin < 9.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3 x 10^9/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
4 sites in 1 country.
Thailand4 sites
Siriraj Hospital, Mahidol University
Bangkok
Lampang Cancer Center
Lampang, 52000
Ubon Ratchanthani Cancer Hospital
Ubon Ratchathani
Udon Thani Cancer Hospital
Udon Thani, Changwat Udon Thani, 41000
About this study
Official title: A Randomized, Double Blind and Placebo Controlled Multicenter Study Comparing BP-C1 and an Equal Looking Placebo in Metastatic Breast Cancer Patients. A Phase IIB Study
The purpose of this study is to determine whether BP-C1 is effective in the short-term treatment of metastatic breast cancer patients who have previously undergone at least three lines of chemotherapy.
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 а 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.
This study is a randomised, double-blind, placebo-controlled, multicentre, phase IIb study in Thai patients with metastatic breast cancer. The eligible patients will be allocated (1:1) to either BP-C1 arm or Placebo arm and treated once daily for 32 days. The patients allocated to Placebo arm will cross over to BP-C1 treatment for 32 days when progression of the cancer will be documented and latest after 32-day treatment with Placebo. After 32-day treatment with BP-C1 the patients are invited to continue open-label treatment under protocol BMC2011-02.
- Conditions
- Metastatic Breast Cancer, Stage IV Breast Cancer
- Being tested
- BP-C1, Placebo
- 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
- 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; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days
PlaceboDrug
Placebo, solution for injection; doses: 0.07 mL/kg body weight intramuscularly once daily for 32 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| BP-C1 | Experimental | Patients allocated to BP-C1 arm will be treated for 32 consecutive days. Patients who respond to treatment and do not experience untolerated toxicity will be invited to participate in the BMC2011-02 study, where they are offered to continue treatment with BP-C1. Receives: Drug: BP-C1 |
| Placebo | Placebo comparator | Patients allocated to Placebo arm will be treated for 32 consecutive days. Thereafter the patients will cross over to 32-day treatment with BP-C1. Patients who respond to treatment and do not experience untolerated toxicity will be invited to participate in the BMC2011-02 study, where they are offered to continue treatment with BP-C1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (%) in the sum of diameters of target lesions
Diameter of target lesions will be measured by computer tomography (CT) with contrasting using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: baseline to Day 32 of treatment
Secondary outcomes (8)
Number of target lesions
Number of target lesions per each patient will be evaluated by CT with contrasting. Number of target lesions at baseline and Day 32 of treatment will be presented in shift tables.
Measured: baseline to Day 32 of treatment
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. In addition to the relative increase of 20%, the sum might also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions will also be considered progression.
Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: baseline to Day 32 of treatment
Karnofsky Performance Status (KPS) score
KPS describes an outcome in 11 grades, starting as normal without complaints and evidence of disease (equals 100 as the best) and dead (equals 0) as the lowest. KPS score will be assessed every 16 days during 32-day treatment period.
Measured: baseline to Day 16 and Day 32 of treatment
Separate scores of the general questionnaire EORTC QLQ-C30
The EORTC QLQ-C30 is a general quality of life questionnaire for cancer patients. The questionnaire contains 30 questions. Three variables will be obtained from the EORTC QLQ-C30: the sum of scores C1 to C5 denoted as "Physical activity problem last week", the sum of scores C6 to C28 denoted as "Discomfort last week", and the sum of scores C29 and C30 denoted as "Health and quality of life".
Measured: baseline to Day 16 and Day 32 of treatment
Separate scores of the specific questionnaire EORTC QLQ-BR23
The EORTC QLQ-BR23 is a breast cancer-specific quality of life questionnaire. The questionnaire consists of 23 questions. Three variables will be obtained from the EORTC-BR23: the sum of scores BR1 to BR13 denoted as "Breast cancer problem last week", the sum of scores BR14 to BR16 denoted as "Sexual interest and activity last four weeks" and the sum of scores BR17 to BR23 denoted as "Breast cancer related pain and discomfort last week".
Measured: baseline to Day 16 and Day 32 of treatment
Maximum Common Toxicity Criteria (CTC) score
Maximum CTC score will be recorded using NCI Common Toxicity Criteria v2.0 divided in 15 categories.
Measured: baseline to Day 16 and Day 32 of treatment
Change in the Sum CTC score
The Sum CTC score will be a sum of all registered CTC scores by 15 categories.
Measured: baseline to Day 16 and Day 32 of treatment
Number of registered adverse events
Adverse events (AEs) will be coded according to the MedDRA (version 16.1E). AEs will be systemized by system organ class and by preferred term. AEs will be analyzed by severity, seriousness and relatedness to the drug.
Measured: baseline to Day 32 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start5 Jun 2014
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meabco A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meddoc, Norwegian University of Life Sciences
- Responsible party
- Sponsor
- Investigators
- Kritiya Butthongkomvong, MD, Principal investigator, Udon Thani Cancer Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603197
- Sponsor's protocol ID
- MBC-BPC1/IIB
- Status last verified
- Oct 2019
- First submitted
- 17 Jul 2018
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Butthongkomvong K, Raunroadroong N, Sorrarichingchai S, Sangsaikae I, Srimuninnimit V, Harling H, Larsen S. Efficacy and tolerability of BP-C1 in metastatic breast cancer: a Phase II, randomized, double-blind, and placebo-controlled Thai multi-center study. Breast Cancer (Dove Med Press). 2019 Jan 14;11:43-51. doi: 10.2147/BCTT.S174298. eCollection 2019.
PubMed 30666153
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind and Placebo Controlled Multicenter Study Comparing BP-C1 and an Equal Looking Placebo in Metastatic Breast Cancer Patients. A Phase IIB Study
- ClinicalTrials.gov ID
- NCT03603197
- Acronym / sponsor ID
- MBC-BPC1/IIB
- 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 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Meabco A/SIndustry (pharma, biotech, devices)
- Collaborators
- Meddoc, Norwegian University of Life Sciences
- Study start
- 5 Jun 2014 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 27 Jul 2018 (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 determine whether BP-C1 is effective in the short-term treatment of metastatic breast cancer patients who have previously undergone at least three lines of chemotherapy.
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 а 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.
This study is a randomised, double-blind, placebo-controlled, multicentre, phase IIb study in Thai patients with metastatic breast cancer. The eligible patients will be allocated (1:1) to either BP-C1 arm or Placebo arm and treated once daily for 32 days. The patients allocated to Placebo arm will cross over to BP-C1 treatment for 32 days when progression of the cancer will be documented and latest after 32-day treatment with Placebo. After 32-day treatment with BP-C1 the patients are invited to continue open-label treatment under protocol BMC2011-02.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP-C1 | Experimental | Drug: BP-C1Patients allocated to BP-C1 arm will be treated for 32 consecutive days. Patients who respond to treatment and do not experience untolerated toxicity will be invited to participate in the BMC2011-02 study, where they are offered to continue treatment with BP-C1. |
| Placebo | Placebo comparator | Drug: PlaceboPatients allocated to Placebo arm will be treated for 32 consecutive days. Thereafter the patients will cross over to 32-day treatment with BP-C1. Patients who respond to treatment and do not experience untolerated toxicity will be invited to participate in the BMC2011-02 study, where they are offered to continue treatment with BP-C1. |
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; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days | Drug | BP-C1 |
| PlaceboPlacebo, solution for injection; doses: 0.07 mL/kg body weight intramuscularly once daily for 32 consecutive days | Drug | Placebo |
Primary outcome
Change (%) in the sum of diameters of target lesions
Time frame: baseline to Day 32 of treatment
Diameter of target lesions will be measured by computer tomography (CT) with contrasting using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
8 secondary outcomes
Number of target lesions
Time frame: baseline to Day 32 of treatment
Treatment response
Time frame: baseline to Day 32 of treatment
Karnofsky Performance Status (KPS) score
Time frame: baseline to Day 16 and Day 32 of treatment
Separate scores of the general questionnaire EORTC QLQ-C30
Time frame: baseline to Day 16 and Day 32 of treatment
Separate scores of the specific questionnaire EORTC QLQ-BR23
Time frame: baseline to Day 16 and Day 32 of treatment
Maximum Common Toxicity Criteria (CTC) score
Time frame: baseline to Day 16 and Day 32 of treatment
Change in the Sum CTC score
Time frame: baseline to Day 16 and Day 32 of treatment
Number of registered adverse events
Time frame: baseline to Day 32 of treatment
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 7 Oct 2019.
- Results publication: PubMed 30666153Butthongkomvong K, Raunroadroong N, Sorrarichingchai S, Sangsaikae I, Srimuninnimit V, Harling H, Larsen S. Efficacy and tolerability of BP-C1 in metastatic breast cancer: a Phase II, randomized, double-blind, and placebo-controlled Thai multi-center study. Breast Cancer (Dove Med Press). 2019 Jan 14;11:43-51. doi: 10.2147/BCTT.S174298. eCollection 2019.
- Efficacy and tolerability of BP-C1 in metastatic breast cancer: a Phase II, randomized, double-blind, and placebo-controlled Thai multi-center study.Link 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.
Kritiya Butthongkomvong, MD principal investigator
Udon Thani Cancer Hospital, Thailand
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BP-C1 in people with Metastatic Breast Cancer and Stage IV Breast Cancer, run by Meabco A/S at 4 sites in Thailand.
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 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 the sum of diameters of target lesions (time frame: baseline to Day 32 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03603197, which also lists 1 linked publication.
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 7 Oct 2019.