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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2017-01-13 |
| Est. Completion | 2020-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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