A Phase 2 interventional study of BP-C1 and BP-C2 in Metastatic Pancreatic Cancer and Unresectable Pancreatic Cancer, sponsored by Meabco A/S. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-11-15.
Sponsored by Meabco A/S · Phase 2, Interventional, and Treatment
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:
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.
3,311 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's enrollment of 16 is below the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Meabco A/S is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients fulfilling at least one of the following criteria will be excluded from participation in the study:
Patients will be treated with BP-C1 for 32 consecutive days
Drug: BP-C1
Patients will be treated with BP-C1 and BP-C2 for 32 consecutive days
Drug: BP-C1 · Drug: BP-C2
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
Also known as: Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin, Benzene polycarboxylic acids complex with cis-diammineplatinum(II)
BP-C2, 0.15% solution for oral use; 15 ml orally once daily for 32 consecutive days
Also known as: molybdenum salts of benzene-polycarboxylic acids
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
Time frame: baseline to 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
Time frame: baseline to Day 32 of treatment
Sum CTC score
The Sum CTC score will be a sum of all registered CTC scores by 15 categories
Time frame: 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.
Time frame: baseline to Day 32 of treatment
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"
Time frame: 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.
Time frame: screening to Day 32 of treatment and Day 28 of follow-up
Plan to share: No
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Ran from Dec 2014 to primary completion in Mar 2016, 14 months.
Of 67 industry-sponsored phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 71. This study's 14 months is below that.
Counting every sponsor, half of 364 studies reached it within 57 months; a quarter within 34 and three quarters within 80.
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Meabco A/S