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.
Multi-year study finds 'hotspots' of ammonia over world's major agricultural areas
17.03.2017 | University of Maryland
Diabetes Drug May Improve Bone Fat-induced Defects of Fracture Healing
17.03.2017 | Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke
Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.
The results will be published on March 22 in the journal „Astronomy & Astrophysics“.
Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...
Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.
Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...
In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...
Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.
Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...
Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to simulate these confined natural conditions in artificial vesicles for the first time. As reported in the academic journal Small, the results are offering better insight into the development of nanoreactors and artificial organelles.
Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to...
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