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NCT02323113 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, and Efficacy of TAK-659 in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (AML)

A Phase 1 study, sponsored by Calithera Biosciences.

Terminated
Registry status
Phase 1
Development phase
43
Enrollment target

NCT02323113 is a Phase 1 study that was terminated before completion, run by Calithera Biosciences. The registered enrollment target is 43 participants.

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The verdict

NCT02323113, a Phase 1 study, was terminated before completion, sponsored by Calithera Biosciences.

TERMINATED
Registry status
Phase 1
Development phase
43 participants
Enrollment target

Study Summary

The purpose of the Phase 1b dose finding phase is to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-659 in participants with relapsed or refractory AML. The purpose of the Phase 2 expansion phase is to evaluate preliminary efficacy of TAK-659 in relapsed or refractory AML as measured by overall response rate (ORR).

Interventions

  • DRUG TAK-659

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2015-03-09
Est. Completion 2018-08-15
Phase Phase 1

Sponsor

Calithera Biosciences

22 total trials

What the Registry Record Tells You About NCT02323113

The ClinicalTrials.gov registry entry for NCT02323113 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calithera Biosciences, which has 22 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which TAK-659 is the first listed.

NCT02323113 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02323113 about?

NCT02323113 is a clinical study titled "Safety, Tolerability, and Efficacy of TAK-659 in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (AML)". The purpose of the Phase 1b dose finding phase is to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-659 in participants with relapsed or refractory AML. The purpose of the Phase 2 expansion phase is to evaluate preliminary efficacy of TAK-...

What is the current status of trial NCT02323113?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2015-03-09. Estimated completion is 2018-08-15.

What interventions are being tested in trial NCT02323113?

The interventions under investigation include: TAK-659 (DRUG).

Who is sponsoring clinical trial NCT02323113?

This trial is sponsored by Calithera Biosciences, which has 22 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.