Testicular Cancer Clinical Trial
Official title:
Phase I Study of the Hypomethylating Drug SGI-110 Plus Cisplatin in Relapsed Refractory Germ Cell Tumors
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.
Primary Objective:
To assess the safety and toxicity of guadecitabine (SGI-110) plus cisplatin including the
dose limiting toxicity (DLT) and to determine the Maximum tolerated dose (MTD)
Secondary Objective:
To assess the efficacy of guadecitabine (SGI-110) to resume sensitivity to cisplatin in
refractory GCT
Correlative Objective:
To evaluate the pharmacodynamic activity of guadecitabine (SGI-110) Evaluate miRNA biomarkers
in serum on day 1 of cycles 1-6
Intervention and Mode of Delivery: Guadecitabine (SGI-110) will be given subcutaneously,
daily, 30 mg/m2 on days (1-5) followed by cisplatin 100mg/m2 on day 8 every 4 weeks.
Duration of Intervention and Evaluation:
Treatment will be continued for a maximum of 6 cycles or until disease progression or
unacceptable toxicity whichever occurs first. Subjects who are responding to therapy without
major toxicty would be allowed to continue on single agent guadecitabine (SGI-110) at the MTD
after 4-6 cycles of the combination therapy until disease progression. Subjects will be
followed after the last cycle every 2 months for the 1st year, and every 4 months thereafter
until death (expected overall survival less than 12 months).
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