NCT02429466

Study of the Hypomethylating Drug Guadecitabine (SGI-110) Plus Cisplatin in Relapsed Refractory Germ Cell Tumors

Phase I Study of the Hypomethylating Drug SGI-110 Plus Cisplatin in Relapsed Refractory Germ Cell Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Nasser Hanna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Germ Cell Tumor
• Testis Cancer
• Testicular Cancer

Interventions

Type	Name	Description
DRUG	Guadecitabine (SGI-110)	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.

Timeline

• Start date: 2015-04-27
• Primary completion: 2018-06-04
• Completion: 2019-02-13
• First posted: 2015-04-29
• Last updated: 2020-09-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study