BP-C1 in Short-term Treatment of Patients With Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title: A Randomized, Double Blind and Placebo Controlled Multicenter Study Comparing BP-C1 and Equal Looking Placebo in Metastatic Breast Cancer Patients. A Phase IIB Study

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether BP-C1 is effective in the treatment of metastatic breast cancer patients who had previously received at least three lines of chemotherapy.

Clinical Trial Description

BP-C1, solution for injection 0.05%, is currently being developed for treatment of patients with metastatic breast cancer with palliative intent. Active substance of the product, which is a novel platinum-containing anticancer agent developed for intramuscular administration, is a cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin. 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 of metastatic breast 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;

• demonstrates efficacy comparable to cisplatin and much higher than carboplatin (in-vitro; in-vivo data);

• exerts an additional immunomodulatory activity.

This study is a randomised, double-blind, placebo-controlled, multicentre, phase IIb study. The eligible patients will be allocated (1:1) to either BP-C1 arm or Placebo arm and treated once daily for 32 days. The patients allocated to Placebo arm will cross over to BP-C1 treatment for 32 days when progression of the cancer will be documented and latest after 32-day treatment with Placebo. After 32-day treatment with BP-C1 the patients are invited to participate in the study BMC2011-02 to continue open-label BP-C1 treatment. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Stage IV Breast Cancer

• NCT number: NCT02783794
• Study type: Interventional
• Source: Meabco A/S
• Status: Completed
• Phase: Phase 2
• Start date: December 24, 2012
• Completion date: February 28, 2014