Atossa: IDMC-Fulvestrant Trial Site Change, New Timelines
Edison | Jan 11, 2017 08:00AM ET
Atossa Genetics Inc (NASDAQ:ATOS) announced this week that it is transferring the site of its ongoing 30-pt Phase II study on intraductal catheter (IDMC) administered fulvestrant to the Montefiore Medical Center in New York City, from the Columbia University Medical Center where it had been initiated in March 2016.
This move follows the relocation of the study’s primary investigator, Dr Sheldon M Feldman, from Columbia to Montefiore. Atossa believes this move will hasten patient recruitment, which it acknowledges had been slower than expected. It now expects to finish enrolment by August 2017, whereas it previously guided completion by March 2017.
The ongoing open-label IDMC-fulvestrant study is comparing the safety, tolerability and pharmacokinetics following the IDMC instillation of fulvestrant, compared to intramuscular (IM) administration, in patients with breast cancer or ductal carcinoma in situ who are scheduled for mastectomy or lumpectomy. The primary outcome measure is the number and severity of adverse events at four weeks using the National Cancer Institute’s CTCAE v4.0 protocol.
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