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NCT02907359 · ClinicalTrials.gov registry record · Phase 3

Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs

A Phase 3 study, sponsored by Astex Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
417
Enrollment target

NCT02907359 is a Phase 3 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 417 participants.

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The verdict

NCT02907359, a Phase 3 study, has completed, sponsored by Astex Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
417 participants
Enrollment target

Study Summary

A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.

Interventions

  • DRUG Guadecitabine
  • OTHER Treatment Choice

Trial Details

FieldValue
Enrollment Target 417 participants
Start Date 2017-01-13
Est. Completion 2020-11-30
Phase Phase 3

Sponsor

Astex Pharmaceuticals

38 total trials

What the Registry Record Tells You About NCT02907359

The ClinicalTrials.gov registry entry for NCT02907359 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 417 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astex Pharmaceuticals, which has 38 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Guadecitabine is the first listed.

NCT02907359 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02907359 about?

NCT02907359 is a clinical study titled "Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs". A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in appr...

What is the current status of trial NCT02907359?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 417 participants. The study started on 2017-01-13. Estimated completion is 2020-11-30.

What interventions are being tested in trial NCT02907359?

The interventions under investigation include: Guadecitabine (DRUG), Treatment Choice (OTHER).

Who is sponsoring clinical trial NCT02907359?

This trial is sponsored by Astex Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.