This multicenter randomized trial is planned to enroll 280 patients. In the first phase of the study, eight study centers will participate in Germany and Switzerland, with the first three patients already enrolled in Lowenstein, Germany. The study is sponsored by CESAR and supported by Saladax Biomedical.
The CEPAC-TDM study is the first large scale, randomized trial to evaluate the clinical utility of paclitaxel drug dose management and is the largest randomized trial of its type. A dosing algorithm has been derived that uses 24-hour paclitaxel plasma concentration and clinical parameters, based on a large population model of paclitaxel. In addition to the clinical results, extensive data on health economic outcomes will be generated through the trial.
Markus Joerger, MD PhD, explains: "The CEPAC-TDM clinical trial has the potential to markedly improve patient quality of life through a reduction of febrile neutropenia and hospitalization, and debilitating neuropathy, as it tailors paclitaxel to the individual patient's drug metabolism."
The CEPAC-TDM study is a phase III open-label, randomized, parallel-group clinical trial comparing conventional dosing of paclitaxel at 200 mg/m2 every three weeks (conventional treatment Arm A) with paclitaxel blood level testing and subsequent individual dose adjustments (experimental treatment Arm B), with the primary objective to significantly reduce grade 4 neutropenia in patients within treatment Arm B, without adversely affecting chemotherapy efficacy in terms of progression-free survival (PFS) and overall survival (OS). Saladax is developing a nanoparticle-based automated immunoassay to provide rapid, simple and cost-effective measurement of paclitaxel levels to allow timely personalized dose adjustment.
About non-small cell lung cancer (NSCLC)
Lung cancer is the most common cancer in the world today, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of all cases. According to the Centers for Disease Control and Prevention (CDC), about 90% of lung cancer deaths in men and almost 80% of lung cancer deaths in women are due to smoking. Treatment for NSCLC varies depending on the stage of the cancer, though combinations of taxanes are routinely used as part of first-line therapy treatment regimens. Common side effects of taxanes include polyneuropathy and bone marrow suppression which results in severe neutropenia.
About pharmacokinetic-guided dosing
There is increasing evidence for the relationship between paclitaxel plasma concentrations, drug-associated toxicity, especially neutropenia and clinical outcome. These data are derived from various pharmacological studies in patients with solid tumors, including lung cancer, ovarian cancer, breast cancer and less frequent cancer types. The aim of TDM is to decrease toxicity while maintaining or improving treatment efficacy as compared to the standard of care. Prospective pharmacokinetic studies with dose adjustments are important to evaluate the value of paclitaxel TDM.
About the CESAR Central European Society for Anticancer Drug Research-EWIV
In the context of the pan-European Early Drug Development Network, CESAR represents the Central European platform for new development of novel drugs and therapies in oncology. The scientific activity in the Working Groups encompasses the development of active substances (AWO), pharmacokinetic studies (APOH) and clinical studies in Phase I, II and III. CESAR fosters cooperation with academic study groups, individual institutions in oncology and the pharmaceutical industry. The CESAR Central Office (CCO) in Vienna offers the appropriate infrastructure for all phases of clinical trials, ranging from planning and implementation to project management, clinical documentation and statistical analyses. CESAR, as a European Economic Interest Grouping (EEIG), is the umbrella organization of the registered societies CESAR Germany and CESAR Austria (with members from Austria and Switzerland).
About Saladax Biomedical, Inc.
Saladax Biomedical develops and commercializes novel diagnostic assays to achieve the promise of personalized medicine through dose management and companion diagnostic products for existing and new therapeutics. Founded in 2004 and based in Bethlehem, PA, the company's dose management technology enables physicians to optimize the dose of drugs to meet individual patient needs, thus leading to improved response and better quality of life. The Company's portfolio of 15 MyCare™ dose management assays is comprised of proprietary, automated and cost-effective in vitro diagnostic tests in various stages of development, with a principal focus in the field of oncology. The first MyCare assay available to the oncology community is for one of the most common anticancer drugs, 5-fluorouracil, commonly referred to as 5-FU. This assay is available in the United States from Myriad Genetics under the trade name OnDose™, sold by Saladax in Europe with CE Mark clearance as My5-FU® and will be distributed in Japan exclusively by FALCO biosystems. Saladax also works with pharmaceutical companies to develop companion diagnostics to provide important clinical information to assist in the development and administration of new and existing compounds. The Company has entered into a multi-year development and commercialization agreement with Bristol-Myers Squibb Company (NYSE: BMY) for the development of certain clinical diagnostic tests to be used in conjunction with the development of certain therapeutic compounds in the BMS pipeline.My5-FU is a registered trademark of Saladax Biomedical, Inc.
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