Study of the Hypomethylating Drug Guadecitabine (SGI-110) Plus Cisplatin in Relapsed Refractory Germ Cell Tumors
Status:
Completed
Trial end date:
2019-02-13
Target enrollment:
Participant gender:
Summary
This is an open-label, single arm, Phase I dose escalation study in subjects with refractory
germ cell tumor (rGCT). This phase I will evaluate the safety and efficacy of SGI-110 in
combination with cisplatin in subjects with rGCT. The primary objective is to determine the
maximum tolerated dose (MTD) of SGI-110 to be used prior to cisplatin. A total of 15 subjects
will be enrolled in this study at the Indiana University Simon Cancer Center.