Dose-finding Study of BP-C1 in Patients With Stage IV Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title: Estimation of Maximum Tolerable Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in Stage IV Breast Cancer Patients: A Phase I Dose-response Study

Status Completed

Clinical Trial Summary

The purpose of this study is to estimate the cumulative Maximum Tolerated Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in the short-term treatment of metastatic breast cancer patients.

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.

In this study BP-C1 will be administered as supportive care to patients with metastatic breast cancer (stage IV), who had undergone at least three lines of chemotherapy.

This study will be open-label, multi-centre with a sequential safety design based on 3-level between-patient Response Surface Pathway (RSP) algorithm. The eligible patients will be allocated to five independent sequences, with three patients in each sequence. The BP-C1 treatment period will be 32 days, the follow-up period will be 28 days after the last BP-C1 dose. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04298333
• Study type: Interventional
• Source: Meabco A/S
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2009
• Completion date: January 4, 2011