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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: Completed Phase 3 study, sponsored by Astex Pharmaceuticals.

NCT02907359 is a Phase 3 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 417 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

OS was defined as the number of days from the day the participant was randomized to the date of death due to any cause. Survival time was censored on the last date the participant is known alive with no event of death. OS time will be estimated using the Kaplan-Meier method.

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
Astex Pharmaceuticals

38 total trials

What the finished NCT02907359 record still lists

NCT02907359 is an interventional study that assigns participants to a tested intervention. The registered 417 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).

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

NCT02907359 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02907359's enrollment target sits among peer trials

417 902nd of 2000 higher than 1,099 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02907359, the US trial registry maintained by the National Library of Medicine. NCT02907359 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.