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NCT02668653 · ClinicalTrials.gov registry record · Phase 3

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

A Phase 3 study, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 3
Development phase
539
Enrollment target

NCT02668653: Completed Phase 3 study, sponsored by Daiichi Sankyo.

NCT02668653 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 539 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02668653, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 3
Development phase
539 participants
Enrollment target

Study Summary

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

Primary Outcome

Overall survival is defined as the time from randomization until death from any cause.

Interventions

  • DRUG Placebo
  • DRUG Chemotherapy
  • DRUG Quizartinib

Trial Details

FieldValue
Enrollment Target 539 participants
Start Date 2016-09-01
Est. Completion 2023-06-16
Phase Phase 3
Daiichi Sankyo

236 total trials

What the finished NCT02668653 record still lists

NCT02668653 is an interventional study that assigns participants to a tested intervention. The registered 539 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 (30% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02668653 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02668653 about?

NCT02668653 is a clinical study titled "Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)". Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizar...

What is the current status of trial NCT02668653?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 539 participants. The study started on 2016-09-01. Estimated completion is 2023-06-16.

What interventions are being tested in trial NCT02668653?

The interventions under investigation include: Placebo (DRUG), Chemotherapy (DRUG), Quizartinib (DRUG).

Who is sponsoring clinical trial NCT02668653?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02668653's enrollment target sits among peer trials

539 700th of 2000 higher than 1,301 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 NCT02668653, the US trial registry maintained by the National Library of Medicine. NCT02668653 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.