Food and Drug Administration

Description

This award is intended to provide support to conduct clinical studies at a clinical site with capability and patients samples to investigate potential biomarker (cMLC1) for trastuzumab-induced cardiotoxicity. 1) There will be an establishment of the assay to quantitatively measure cMLC-1 in humans. 2) Investigations will be conducted to determine the value of cMLC-1 in humans as an early predictor of cardiotoxicity in a pilot study. A comparison will be done of the level of cMLC-1 in 5 patients who subsequently developed cardiotoxicity and 5 patients who did not. Patients will be matched for age. Cardiotoxicity was defined using the Cardiac Review and Evaluation Committee for Trastuzumab (CREC) criteria as a decrease of more than 10% in the echocardiographic left ventricular ejection fraction to a value of less than 55%. 3) Women were monitored every 3 months for 15 months. 4) The archived plasma samples collected at multiple time points indicated below schematically will be tested for the biomarker cMLC-1 and for troponin I, an established marker for heart muscle damage as a control.

Who can apply

• Others

Contact

Shashi Malhotra <br/>Grants Management Specialist <br/>Phone( 240)402-7592
shashi.malhotra@fda.hhs.gov