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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: Completed Phase 1 study of Germ Cell Tumor and Testicular Cancer, sponsored by Nasser Hanna.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
Interventions
- DRUG Guadecitabine (SGI-110)
Study Locations (2)
Indiana
- Indiana University Hospital - Indianapolis
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-04-27 |
| Est. Completion | 2019-02-13 |
| Phase | Phase 1 |
What the finished NCT02429466 record still lists
NCT02429466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 347-participant average among 19 other Germ Cell Tumor trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02429466's enrollment target sits among peer trials
14 18th of 19 higher than 2 of 19 other Germ Cell Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Germ Cell Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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