Merck suspends enrollment of MK-0457 trials
Vertex (VRTX) said partner MRK suspended enrollment in trials of MK-0457 (VX-680) after QTc prolongation was observed in one patient in a Phase II trial to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL). The small molecule inhibitor of aurora kinases and FLT3 kinase also is in a Phase I trial in the same indication in combination with dasatinib and a Phase I to treat advanced leukemia. Patients already enrolled in the trials may continue to receive MK-0457, with additional monitoring for QTc prolongation.
MRK did not disclose the number of patients that have been treated with MK-0457. The Phase II trial was expected to enroll 270 patients, and a previous Phase I trial enrolled 44 CML and Ph+ ALL patients. Bristol-Myers (BMY) markets Sprycel dasatinib. MRK said it does not know what caused the QTc prolongation, but that it is not an uncommon event in similar trials. ...