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Cisplatin

BP-C1 given in daily intramuscular doses of 0.035 mg/kg bodyweight in one syringe per day during a total treatment of 32 days.

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

BP-C1

Stig Larsen, Prof.

This study is an open label, non-randomized phase I single-armed study in women with metastatic breast cancer (MBC) who have previously undergone all available standard chemotherapy regimens. The purpose of the study is to estimate the pharmacokinetics (PK) after single dose and multiple dose of BP-C1, investigate interleukin levels during BP-C1 treatment and assess treatment response according to RECIST criteria.

BP-C1, solution for injections 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.

In this study six female patients with MBC who have previously undergone at least third line therapy will be enrolled. Each included patient will participate in a screening period (maximum duration of 21 days) following by 32-day treatment period and 28-day follow-up period.

The patients will be treated with BP-C1(daily intramuscular injections) for 32 consecutive days. The study is undertaken to evaluate pharmacokinetics, pharmacodynamics and treatment effect of BP-C1.

BP-C1 in Metastatic Breast Cancer Patients

Pharmacokinetic, Pharmacodynamic and Interleukin Profile of Intramuscularly Administered BP-C1 in Women With Metastatic Breast Cancer. A Phase ID Study

Maximum Observed Serum Concentration (Cmax) for Platinum after the single dose of BP-C1 during the period of Day-1 to Day 1

Time to Reach Maximum Observed Serum Concentration (Tmax) for Platinum after the single dose of BP-C1 during the period of Day-1 to Day 1

AUC(0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration after the single dose of BP-C1 during the period of Day-1 to Day 1

after the single dose of BP-C1 during the period of Day-1 to Day 1

Serum decay half-life is the time measured for the serum concentration of Platinum to decrease by one half after the single dose of BP-C1 during the period of Day-1 to Day 1

Maximum Observed Serum Concentration at steady state (Css,max) for Platinum during the period of Day 32 to Day 34

Time for Css,max at steady state for Platinum during the period of Day 32 to Day 34

Minimum Observed Serum Concentration at Steady State (Css,min) for Platinum during the period of Day 32 to Day 34

Average Serum concentration at steady state (Css,av) for Platinum during the period of Day 32 to Day 34

Area under the serum concentration versus time curve within a dosing interval of tau (=24 hr) at steady state (AUCss,tau) during the period of Day 32 to Day 34

Serum decay half-life is the time measured for the plasma concentration of Platinum to decrease by one half during the period of Day 32 to Day 34

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

Number of target lesions per each patient will be evaluated by CT with contrasting. Change in number of target lesions from baseline to Day 32 of treatment will be presented in shift tables

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

Meabco A/S

Symptoms and General Pathology

Neoplasm Metastasis

Dose-response part: patients who have completed the first 32-day treatment period with BP-C1 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4, and having a maximum of "moderate" toxicity at the end of treatment are offered to continue in the second 32-day treatment period with BP-C1 under the protocol BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28 days.

Follow-up study: the patients will be given BP-C1 as long as they obtain benefit from the treatment (i.e. until disease progression or increase in toxicity not above "moderate" grade).

Henning Arboe

The purpose of this study is to establish an optimal treatment duration and tolerable cumulative dose for BP-C1 in the treatment of metastatic breast cancer patients who had previously undergone at least three lines of chemotherapy.

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 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 an open-label, non-randomised, single-group, multi-centre study with a sequential safety design. The study consists of two parts: dose-response part and follow-up study.

Dose-response part: Patients who have completed the first 32-day treatment period with BP-C1 from Day 1 to Day 32 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4, and having a maximum of "moderate" toxicity at the end of treatment are offered to continue in the second 32-day treatment period with BP-C1 from Day 33 to Day 64 under protocol BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28 days.

Follow-up study: After 28-day follow-up period the patients without disease progression and without an increase in toxicity are offered to participate in the follow-up study. During the follow-up study the patients will be given BP-C1 as long as they obtain benefit from the treatment (i.e. until disease progression or increase in toxicity not above "moderate" grade).

BP-C1 Monotherapy in Patients With Metastatic Breast Cancer Cancer: Estimation of Optimal Duration of Treatment

Estimation of the Optimal Treatment Duration and Cumulative Dose of BP-C1 in Breast Cancer Patients With Distant Metastases: a Dose-response Study (IC)

Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Sum CTC score will be calculated by taking the sum of each variable across all categories.

Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Maximum CTC score will be calculated by taking the maximum value among all variables across all categories.

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

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.

KPS score will give an outcome with 11 grades, starting as normal status without complaints and evidence of disease as the best (KPS score = 100) and the dead status as the lowest (KPS score = 0)

Quality of life sub-scores will be obtained by general cancer questionnaire EORTC QLQ-C30. EORTC QLQ-C30 consists of 30 questions generally related to cancer. The questionnaire will be self-administered and will be given in patient's mother tongue. EORTC QLQ-C30 (version 3) is divided in the 3 major scales that will be presented as 15 sub-scores: i) global health status; ii) functional scale (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning); iii) symptom scale/item(fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). Range of functional scale is 0-100 (high values are "better"). Range of symptom scale is 0-100 (low values are "better").

Quality of life sub-scores will be obtained by specific breast cancer questionnaire EORTC QLQ-BR23. EORTC QLQ-BR-23 consists of 23 questions related to breast cancer. The questionnaire will be self-administered and will be given in patient's mother tongue. EORTC QLQ-BR23 is divided in 2 scales that will be presented as 8 sub-scores: i) functional scale (body image, sexual functioning, sexual enjoyment, future perspective); ii) symptom scale/item (systemic therapy side effect, breast symptom, arm symptom, upset by hair loss). Range of functional scale is 0-100 (high values are "better"). Range of symptom scale is 0-100 (low values are "better").

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.

Meddoc

Norwegian University of Life Sciences

Patients randomized to BP-C1 arm will be treated for 32 consecutive days. Patients who respond to treatment and do not experience untolerated toxicity are invited to participate in the BMC2011-02 study, where they will be offered to continue treatment with BP-C1.

Patients randomized 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 are invited to participate in the BMC2011-02 study, where they will be offered to continue treatment with BP-C1.

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

Placebo

Steen Lindkær-Jensen, MD

The purpose of this study is to determine whether BP-C1 is effective in the treatment of metastatic breast cancer patients who had previously received at least three lines of chemotherapy.

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.

This study is a randomised, double-blind, placebo-controlled, multicentre, phase IIb study. 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 participate in the study BMC2011-02 to continue open-label BP-C1 treatment.

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

A Randomized, Double Blind and Placebo Controlled Multicenter Study Comparing BP-C1 and Equal Looking Placebo in Metastatic Breast Cancer Patients. A Phase IIB Study

Number of target lesions per each patient will be evaluated by CT with contrasting. Change in number of target lesions from baseline to Day 32 of treatment will be presented in shift tables.

Number of non-target lesions per each patient will be evaluated by CT with contrasting. Change in number of non-target lesions from baseline to Day 32 of treatment will be presented in shift tables.

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.

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.

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".

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

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

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Micronutrients

Molybdenum

Trace Elements

Patients will be treated with BP-C1 for 32 consecutive days

Patients will be treated with BP-C1 and BP-C2 for 32 consecutive days

BP-C1, 0.05% solution for injections; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days

BP-C2, 0.15% solution for oral use; 15 ml orally once daily for 32 consecutive days

BP-C2

Tarek Ibrahim, MD

The aim of this study is to investigate the short-term effect and tolerability BP-C1 in patients with metastatic pancreatic cancer who has undergone guideline-recommended chemotherapy.

BP-C1, solution for injections 0.05%, is currently being developed for treatment of patients with metastatic breast cancer and metastatic pancreatic cancer with palliative intent. Active substance of the product, which is a novel platinum-containing anticancer agent developed for intramuscular administration, is a complex between cis-diammineplatinum(II) derived core and an amphiphilic polymer, containing a composition of benzene polycarboxylic acids. 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 in metastatic 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;
* exerts an additional immunomodulatory activity.

BP-C2 is a novel lignin-derived polyphenolic composition with ammonium molybdate. BP-C2, given orally, is believed to reduce the toxicity of chemotherapeutic agents.

This is a single center, two arm, open label pilot study (phase IIa). The eligible patients will be allocated either to BP-C1 arm or to BP-C1+BP-C2 arm and treated for 32 days with further follow-up for 28 days.

BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer

The Effect of BP-C1 in Treatment of Inoperable Pancreatic Cancer Patients: A Single Centre Pilot Study

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

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

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

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"

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.

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.

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.

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).

Dose-finding Study of BP-C1 in Patients With Stage IV Breast Cancer

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

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

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

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.

The DCR defined as patients classified as SD, PR, CR

Meddoc Research Indonesia Ltd

Meddoc Research Taiwan Ltd

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.

Kritiya Butthongkomvong, MD

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.

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.

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

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BP-C1 in Metastatic Breast Cancer Patients	NCT01861509	Metastatic Brea... Stage IV Breast...	BP-C1	18 Years - 80 Years	Meabco A/S
BP-C1 Monotherapy in Patients With Metastatic Breast Cancer Cancer: Estimation of Optimal Duration of Treatment	NCT03789019	Metastatic Brea... Stage IV Breast...	BP-C1	18 Years - 80 Years	Meabco A/S
BP-C1 in Short-term Treatment of Patients With Metastatic Breast Cancer	NCT02783794	Metastatic Brea... Stage IV Breast...	BP-C1 Placebo	18 Years - 80 Years	Meabco A/S
BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer	NCT03627390	Metastatic Panc... Unresectable Pa...	BP-C1 BP-C2	18 Years - 80 Years	Meabco A/S
Dose-finding Study of BP-C1 in Patients With Stage IV Breast Cancer	NCT04298333	Metastatic Brea... Stage IV Breast...	BP-C1	18 Years - 80 Years	Meabco A/S
Dose-finding Study of BP-C1 in Patients With Stage IV Breast Cancer	NCT04298333	Metastatic Brea... Stage IV Breast...	BP-C1	18 Years - 80 Years	Meabco A/S
BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer	NCT03627390	Metastatic Panc... Unresectable Pa...	BP-C1 BP-C2	18 Years - 80 Years	Meabco A/S
BP-C1 in Short-term Treatment of Thai Patients With Metastatic Breast Cancer	NCT03603197	Metastatic Brea... Stage IV Breast...	BP-C1 Placebo	18 Years - 80 Years	Meabco A/S

Spots Global Cancer Trial Database for platinum analogue