Clinical Pharmacology & Biopharmaceutics
Open Access

Abstract

BP-C1 is currently used in treating metastatic breast cancer patients, controlling tumor growth, improves quality of life with a few mild side-effects. Methods: The material consists of laboratory results from 47 patients in two controlled clinical trials with daily IM injections of BP-C1 for 32 days. Study I was performed as an open non-randomized, Phase I dose-response study with a 3-level between-patient Response-Surface-Pathway design. The second study as a randomized double-blinded and placebo controlled multicenter study with stratified semi-cross-over design. Results: Hemoglobin and hematocrit increased significantly (p<0.01) during BP-C1 treatment, while red blood cell count increased but not significantly, the most pronounced increase was in anemic patients (pâ�?¤0.01). White blood cell count and neutrophils increased significantly (p= 0.01) in the total material. These variables (p<0.01), eosinophils (p=0.05) and monocytes (p<0.01) increased significantly and markedly in patients with lowest baseline levels. Additionally, low levels of thrombocytes significantly increased. No changes in liver parameters, amylase, glucose, creatinine, or albumin were detected except for albumin in the subgroup with low baseline, where levels increased significantly (p=0.04). An increase in K+, Ca2+ and PO4 3- was most pronounced in patients with low baseline levels (pâ�?¤0.02). A similar pattern detected for Mg2+, PT, KFNT and CRP increased significantly (pâ�?¤0.05) in the groups with the lowest values. Conclusion: Our findings support the safety profile of BP-C1 and did not induce to anemia, infection, bleeding, hepatic insufficiency or electrolyte imbalances, but corrugated abnormalities.

Biography

Stig Larsen has completed his DSc in Clinical Research Methodology at Ullevål Hospital, Oslo University, Norway. He is Professor at the Norwegian University of Life Science and has published more than 300 papers in international medicine and clinical research methodological journals.

Email: stig.larsen@nmbu.no