Dose Escalation Study to Assess the Safety and Tolerability of Genz-644282 in Patients With Solid Tumors
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase I, open-label, multicenter, dose-escalation study designed to assess the
safety and tolerability of Genz-644282, administered as an intravenous (IV) infusion, to
patients with advanced malignant solid tumors. Each 28 day cycle of treatment will consist of
3 consecutive weeks of treatment every 28 days(i.e., treatment will be administered on Days
1, 8, and 15 every 28 days). Each 21 day cycle of treatment will consist of 2 consecutive
weeks of treatment every 21 days(i.e., treatment will be administered on Days 1 and 8 every
21 days). Treatment with Genz-644282 will continue until disease progression or unacceptable
toxicity is observed. Approximately 110 patients will be enrolled in this study. Patients
will be enrolled in escalating dose cohorts until the Maximum Tolerated Doses (MTDs) for the
2 dosing schedules are established. To further evaluate safety, approximately 40 additional
patients with advanced malignant solid tumors will be enrolled and treated at the MTDs (20
for each dosing schedule) during an expansion phase.