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NCT02348489 · ClinicalTrials.gov registry record · Phase 3

SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

A Phase 3 study, sponsored by Astex Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
815
Enrollment target

NCT02348489: Completed Phase 3 study, sponsored by Astex Pharmaceuticals.

NCT02348489 is a Phase 3 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 815 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02348489, a Phase 3 study, has completed, sponsored by Astex Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
815 participants
Enrollment target

Study Summary

To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

Primary Outcome

Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist.

Interventions

  • DRUG SGI-110 (guadecitabine)
  • DRUG Treatment Choice

Trial Details

FieldValue
Enrollment Target 815 participants
Start Date 2015-03-19
Est. Completion 2019-06-17
Phase Phase 3
Astex Pharmaceuticals

38 total trials

What the finished NCT02348489 record still lists

NCT02348489 is an interventional study that assigns participants to a tested intervention. The registered 815 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which SGI-110 (guadecitabine) is the first listed.

NCT02348489 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02348489 about?

NCT02348489 is a clinical study titled "SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction". To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

What is the current status of trial NCT02348489?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 815 participants. The study started on 2015-03-19. Estimated completion is 2019-06-17.

What interventions are being tested in trial NCT02348489?

The interventions under investigation include: SGI-110 (guadecitabine) (DRUG), Treatment Choice (DRUG).

Who is sponsoring clinical trial NCT02348489?

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 NCT02348489's enrollment target sits among peer trials

815 406th of 2000 higher than 1,594 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 NCT02348489, the US trial registry maintained by the National Library of Medicine. NCT02348489 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.