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

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

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