BP-C1 in Short-term Treatment of Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer; Unresectable Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): BP-C1; BP-C2
Intervention type(s): Drug; Drug
Intervention description(s): 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
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); molybdenum salts of benzene-polycarboxylic acids
Intervention MeSH terms: Molybdenum
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, single center, two arm
Masking: None (Open Label)
Primary purpose: Treatment
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