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COMPLETED Phase 1

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

NCT02429466 · View on ClinicalTrials.gov ↗

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

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02429466

The ClinicalTrials.gov registry entry for NCT02429466 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nasser Hanna, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02429466 reports 2 study locations spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02429466?

The interventions under investigation include: Guadecitabine (SGI-110) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02429466?

This trial is sponsored by Nasser Hanna, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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