Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

CESAR Announces Start of Enrollment in Trial of Pharmacokinetic-Guided Dosing in NSCLC

27.04.2011
In collaboration with Saladax Biomedical, Inc., the Central European Society for Anticancer Drug Research (CESAR) announced today that enrollment has begun in the CEPAC-TDM trial of paclitaxel therapeutic drug management (TDM) with subsequent pharmacokinetic-guided dose adjustment in patients being treated for advanced non-small cell lung cancer (NSCLC). The study will determine if optimizing dosing of paclitaxel will reduce grade 4 neutropenia, without affecting progression-free survival and overall survival.

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."

Study details

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.
OnDose is a trademark of Myriad Genetics, Inc.

Dr. Berta Moritz | idw
Further information:
http://www.cesar.or.at
http://www.saladax.com

More articles from Studies and Analyses:

nachricht New study: How does Europe become a leading player for software and IT services?
03.04.2017 | Fraunhofer-Institut für System- und Innovationsforschung (ISI)

nachricht Reusable carbon nanotubes could be the water filter of the future, says RIT study
30.03.2017 | Rochester Institute of Technology

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Making lightweight construction suitable for series production

More and more automobile companies are focusing on body parts made of carbon fiber reinforced plastics (CFRP). However, manufacturing and repair costs must be further reduced in order to make CFRP more economical in use. Together with the Volkswagen AG and five other partners in the project HolQueSt 3D, the Laser Zentrum Hannover e.V. (LZH) has developed laser processes for the automatic trimming, drilling and repair of three-dimensional components.

Automated manufacturing processes are the basis for ultimately establishing the series production of CFRP components. In the project HolQueSt 3D, the LZH has...

Im Focus: Wonder material? Novel nanotube structure strengthens thin films for flexible electronics

Reflecting the structure of composites found in nature and the ancient world, researchers at the University of Illinois at Urbana-Champaign have synthesized thin carbon nanotube (CNT) textiles that exhibit both high electrical conductivity and a level of toughness that is about fifty times higher than copper films, currently used in electronics.

"The structural robustness of thin metal films has significant importance for the reliable operation of smart skin and flexible electronics including...

Im Focus: Deep inside Galaxy M87

The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.

Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...

Im Focus: A Quantum Low Pass for Photons

Physicists in Garching observe novel quantum effect that limits the number of emitted photons.

The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...

Im Focus: Microprocessors based on a layer of just three atoms

Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.

Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Fighting drug resistant tuberculosis – InfectoGnostics meets MYCO-NET² partners in Peru

28.04.2017 | Event News

Expert meeting “Health Business Connect” will connect international medical technology companies

20.04.2017 | Event News

Wenn der Computer das Gehirn austrickst

18.04.2017 | Event News

 
Latest News

Wireless power can drive tiny electronic devices in the GI tract

28.04.2017 | Medical Engineering

Ice cave in Transylvania yields window into region's past

28.04.2017 | Earth Sciences

Nose2Brain – Better Therapy for Multiple Sclerosis

28.04.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>