BP-C1 in Short-term Treatment of Thai Patients With Metastatic Breast Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

BP-C1

Placebo

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Udon Thani Cancer Hospital
Siriraj Hospital, Mahidol University
Lampang Cancer Center
Ubon Ratchanthani Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BP-C1

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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".

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".

Maximum Common Toxicity Criteria (CTC) score

Maximum CTC score will be recorded using NCI Common Toxicity Criteria v2.0 divided in 15 categories.

Change in the Sum CTC score

The Sum CTC score will be a sum of all registered CTC scores by 15 categories.

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.

Full Information

NCT ID

NCT03603197

First Posted

July 17, 2018

Last Updated

October 3, 2019

Sponsor

Meabco A/S

Collaborators

Meddoc, Norwegian University of Life Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03603197

Brief Title

BP-C1 in Short-term Treatment of Thai Patients With Metastatic Breast Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 5, 2014 (Actual)

Primary Completion Date

August 30, 2016 (Actual)

Study Completion Date

August 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meabco A/S

Collaborators

Meddoc, Norwegian University of Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BP-C1

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

BP-C1

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo, solution for injection; doses: 0.07 mL/kg body weight intramuscularly once daily for 32 consecutive days

Primary Outcome Measure Information:

Title

Change (%) in the sum of diameters of target lesions

Description

Diameter of target lesions will be measured by computer tomography (CT) with contrasting using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Time Frame

baseline to Day 32 of treatment

Secondary Outcome Measure Information:

Title

Number of target lesions

Description

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.

Time Frame

baseline to Day 32 of treatment

Title

Treatment response

Description

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.

Time Frame

baseline to Day 32 of treatment

Title

Karnofsky Performance Status (KPS) score

Description

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.

Time Frame