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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03627390
Study type	Interventional
Source	Meabco A/S
Contact
Status	Completed
Phase	Phase 2
Start date	December 19, 2014
Completion date	March 4, 2016

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