Spots Global Cancer Trial Database for BP-C1 in Short-term Treatment of Thai Patients With Metastatic Breast Cancer

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Trial Identification

Brief Title: BP-C1 in Short-term Treatment of Thai Patients With Metastatic Breast Cancer

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

Study ID: NCT03603197

Conditions

Metastatic Breast Cancer

Stage IV Breast Cancer

Interventions

BP-C1

Placebo

Study Description

Brief Summary: The purpose of this study is to determine whether BP-C1 is effective in the short-term treatment of metastatic breast cancer patients who have previously undergone at least three lines of chemotherapy.

Detailed 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 а 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 in Thai patients with metastatic breast cancer. 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 continue open-label treatment under protocol BMC2011-02.