NCT03627390

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Meabco A/S · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Cancer
• Unresectable Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	BP-C1	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
DRUG	BP-C2	BP-C2, 0.15% solution for oral use; 15 ml orally once daily for 32 consecutive days

Timeline

• Start date: 2014-12-19
• Primary completion: 2016-03-04
• Completion: 2016-03-04
• First posted: 2018-08-13
• Last updated: 2018-11-15

Locations

1 site across 1 country: Egypt