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news.The FDA has notified Delcath Systems that patient enrollment may resume in the Phase III and Phase II trials of the Delcath System. Current and prospective clinical investigation sites have been notified that study accrual can be resumed immediately.
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This decision follows Delcath’s meeting with representatives of the FDA, along with the principal investigator at the National Cancer Institute (NCI).
Resumption of study accrual follows a voluntary enrollment deferral announced by the company on October 23, 2007 in response to an FDA inquiry into certain gastrointestinal adverse events observed in four patients enrolled in the studies of the Delcath System prior to protocol changes enacted earlier in 2007.
The Phase III study will evaluate Delcath System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver.