Back to resultsBP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer
Primary Purpose
Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
BP-C1
BP-C2
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring Benzene polycarboxylic acids complex with cis-diammineplatinum(II), BP-C1, Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin, Platinum analogue, Metronomic chemotherapy, Cisplatin, Pancreatic cancer, BP-C2, molybdenum salts of benzene-polycarboxylic acids
Eligibility Criteria
Inclusion Criteria:
- Patients of all genders between 18 and 80 years of age with metastatic pancreatic cancer (unresectable pancreatic cancer with increased levels of cancer antigen 19-9), who 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 >136 μmol/L (8.0 mg/dL)
- Abnormal kidney function defined by serum creatinine >120 μmol/L (1.5 mg/dL).
- Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10 < 0.7 or international normalized ratio >1.5.
- Verified metastases to the brain.
- Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
- Abnormal haematology status defined by hemoglobin < 6.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3 x 10^9/L.
- Clinically significant abnormal ECG.
- Karnofsky performance status score <60%.
- Pregnancy or breast-feeding.
- Women of fertile age who do not want to be tested for possible pregnancy.
- 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
- National Liver Institute, Menoufia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BP-C1
BP-C1+BP-C2
Arm Description
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
Outcomes
Primary Outcome Measures
Change (%) in the sum of diameters of target lesions
Diameter of target lesions will be measured by computer tomography (CT) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Maximum Common Toxicity Criteria (CTC) score
Maximum CTC score will be recorded using NCI Common Toxicity Criteria v2.0 divided in 15 categories
Sum CTC score
The Sum CTC score will be a sum of all registered CTC scores by 15 categories
Secondary Outcome Measures
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.
Scores of the general quality of life cancer 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"
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
NCT03627390
First Posted
July 26, 2018
Last Updated
November 13, 2018
Sponsor
Meabco A/S
Collaborators
Meddoc, Norwegian University of Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03627390
Brief Title
BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer
Official Title
The Effect of BP-C1 in Treatment of Inoperable Pancreatic Cancer Patients: A Single Centre Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 19, 2014 (Actual)
Primary Completion Date
March 4, 2016 (Actual)
Study Completion Date
March 4, 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 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer
Keywords
Benzene polycarboxylic acids complex with cis-diammineplatinum(II), BP-C1, Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin, Platinum analogue, Metronomic chemotherapy, Cisplatin, Pancreatic cancer, BP-C2, molybdenum salts of benzene-polycarboxylic acids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open label, single center, two arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BP-C1
Arm Type
Experimental
Arm Description
Patients will be treated with BP-C1 for 32 consecutive days
Arm Title
BP-C1+BP-C2
Arm Type
Experimental
Arm Description
Patients will be treated with BP-C1 and BP-C2 for 32 consecutive days
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, Benzene polycarboxylic acids complex with cis-diammineplatinum(II)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
BP-C2
Other Intervention Name(s)
molybdenum salts of benzene-polycarboxylic acids
Intervention Description
BP-C2, 0.15% solution for oral use; 15 ml orally 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) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time Frame
baseline to Day 32 of treatment
Title
Maximum Common Toxicity Criteria (CTC) score
Description
Maximum CTC score will be recorded using NCI Common Toxicity Criteria v2.0 divided in 15 categories
Time Frame
baseline to Day 32 of treatment
Title
Sum CTC score
Description
The Sum CTC score will be a sum of all registered CTC scores by 15 categories
Time Frame
baseline to Day 32 of treatment
Secondary Outcome Measure Information:
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
Scores of the general quality of life cancer questionnaire (EORTC QLQ-C30)
Description
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"
Time Frame
baseline to Day 16 and Day 32 of treatment
Title
Number of registered adverse events
Description
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.
Time Frame
screening to Day 32 of treatment and Day 28 of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of all genders between 18 and 80 years of age with metastatic pancreatic cancer (unresectable pancreatic cancer with increased levels of cancer antigen 19-9), who 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 >136 μmol/L (8.0 mg/dL)
Abnormal kidney function defined by serum creatinine >120 μmol/L (1.5 mg/dL).
Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10 < 0.7 or international normalized ratio >1.5.
Verified metastases to the brain.
Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
Abnormal haematology status defined by hemoglobin < 6.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3 x 10^9/L.
Clinically significant abnormal ECG.
Karnofsky performance status score <60%.
Pregnancy or breast-feeding.
Women of fertile age who do not want to be tested for possible pregnancy.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Ibrahim, MD
Organizational Affiliation
Department of HPH Surgery, National Liver Institute, University of Menoufia, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Liver Institute, Menoufia University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer
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