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Terminated Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT02323113

Public ClinicalTrials.gov record NCT02323113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 6:16 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Phase 1b/2 Study Investigating Recommended Phase 2 Dose, Safety, Tolerability, and Preliminary Efficacy of TAK-659 in Adult Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT02323113
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Calithera Biosciences, Inc
Industry
Enrollment
43 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 9, 2015 (Actual)
Primary completion
Jun 8, 2018 (Actual)
Completion
Aug 15, 2018 (Actual)
Last update posted
Feb 8, 2023

2015 – 2018

United States locations

U.S. sites
14
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois 60611 —
Oncology Specialists, S.C. Niles Illinois 60714 —
Johns Hopkins Hospital Baltimore Maryland 21287 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109 —
Karmanos Cancer Center Detroit Michigan 48201 —
Henry Ford Health System Detroit Michigan 48202 —
Mayo Clinic Rochester Minnesota 55905 —
North Shore Long Island Jewish Medical Center New York New York 10024 —
University of North Carolina Hospital Chapel Hill North Carolina 27514 —
UC Health Clinical Trials Office Cincinnati Ohio 45206 —
Baylor University Medical Center Dallas Texas 75204 —
Medical College of Wisconsin, Inc. Milwaukee Wisconsin 53266 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02323113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 8, 2023 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02323113 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →