Study ACCL0431, A Randomized Phase III Study of PEDMARKTM (a unique formulation of Sodium Thiosulfate (STS)) for the Prevention of Cisplatin-Induced Ototoxicity in Children.
Study ACCL0431 was initiated in June 2008 by the Children’s Oncology Group (COG) primarily at sites in the US and Canada. The study enrolled 135 patients most of whom have diagnoses of one of five childhood cancers typically treated with intensive cisplatin therapy, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. Enrollment for the COG-sponsored trial is complete and data were presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The data presented are described under the STS Product Candidate page and in the corporate presentation. See also ClinicalTrials.gov.