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NCT02429466 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Germ Cell Tumor and Testicular Cancer, sponsored by Nasser Hanna.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
2
Study locations

NCT02429466 is a Phase 1 study of Germ Cell Tumor and Testicular Cancer that has completed, run by Nasser Hanna. The registered enrollment target is 14 participants, below the 347-participant average among 19 other Germ Cell Tumor trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT02429466, a Phase 1 study of Germ Cell Tumor and Testicular Cancer, has completed, sponsored by Nasser Hanna.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target
2
Study locations

Study 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.

Interventions

  • DRUG Guadecitabine (SGI-110)

Study Locations (2)

Indiana

  • Indiana University Hospital - Indianapolis
  • Indiana University Melvin and Bren Simon Cancer Center - Indianapolis

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2015-04-27
Est. Completion 2019-02-13
Phase Phase 1

Sponsor

Nasser Hanna

4 total trials

What the Registry Record Tells You About NCT02429466

The ClinicalTrials.gov registry entry for NCT02429466 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 347-participant average among 19 other Germ Cell Tumor trials with a reported enrollment target (96% lower). The listed sponsor is Nasser Hanna, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Germ Cell Tumor appearing as the primary indexed condition, and to 1 intervention - of which Guadecitabine (SGI-110) is the first listed.

NCT02429466 reports 2 study locations spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT02429466 about?

NCT02429466 is a clinical study titled "Study of the Hypomethylating Drug Guadecitabine (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 (MT...

What is the current status of trial NCT02429466?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-04-27. Estimated completion is 2019-02-13.

What conditions does trial NCT02429466 study?

This clinical trial studies the following conditions: Germ Cell Tumor, Testicular Cancer, Testis Cancer.

What interventions are being tested in trial NCT02429466?

The interventions under investigation include: Guadecitabine (SGI-110) (DRUG).

Who is sponsoring clinical trial NCT02429466?

This trial is sponsored by Nasser Hanna, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02429466 being conducted?

This trial has 2 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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