Trial · NCT04079738

Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib

NCT04079738, Phase 1, Phase 2, Terminated, H Scott Boswell; results first posted 2023-09-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib. Trials, record NCT04079738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04079738

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib
NCT number: NCT04079738
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 8 participants, actual
Lead sponsor: H Scott Boswell
Conditions: AML, AML, Adult
Interventions: TAK-659, Ixazomib
First posted: 2019-09-06
Last updated: 2023-09-13
Results first posted: 2023-09-13

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose(s) (RP2D)	At the end of Cycle 2(each cycle is 28 days)	To determine the maximum tolerated dose (MTD) and recommended phase 2 dose(s) (RP2D) of the combination of TAK-659 and Ixazomib in patients with relapsed or refractory AML.
Primary	Overall Response Rate for Phase II Subjects.	Overall Response rate is assessed at the end of 4 cycles ; 4 months.	To evaluate preliminary efficacy of TAK-659 plus Ixazomib in relapsed or refractory AML as measured by overall response rate (ORR). Overall response rate (ORR) defined as CR, CRp, CRi, and PR per Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia.
Secondary	Duration of Response (DOR) for Phase II Subjects	Up to two years after the date of the first documented response.	DOR defined as the time from the date of first documentation of a response to the date of first documented progressive disease
Secondary	Time to Progression (TTP) for Phase II Subjects	time from first dose of study drug until tumor progression up to two years after the date of the first documented response.	TTP defined as the time from first dose of study drug until tumor progression as defined by the Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia
Secondary	Overall Survival (OS) for Phase II Subjects	time from the date of study entry up to two years.	OS defined as the time from the date of study entry to death
Secondary	Frequency of Grade 3 and Higher Adverse Events for Phase II Subjects	From date of first dose until 30 days after the last treatment up to 1 year.	Summarize Grade 3 and higher adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Secondary	Mortality Rate at 3 and 6 Months for Phase II Subjects	From start of treatment up to 2 years or until death.	Number of deaths at 3 and 6 moths are assessed in Phase II subjects.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose(s) (RP2D)	At the end of Cycle 2(each cycle is 28 days)		mg	NUMBER
PRIMARY	Overall Response Rate for Phase II Subjects.	Overall Response rate is assessed at the end of 4 cycles ; 4 months.	This study was terminated due to Funder's decision at Phase I.
SECONDARY	Duration of Response (DOR) for Phase II Subjects	Up to two years after the date of the first documented response.	The study was terminated at phase I due to Funder's decision.
SECONDARY	Time to Progression (TTP) for Phase II Subjects	time from first dose of study drug until tumor progression up to two years after the date of the first documented response.	The study was terminated at Phase I due to Funder's decision
SECONDARY	Overall Survival (OS) for Phase II Subjects	time from the date of study entry up to two years.	This study was terminated at Phase I due to funder's decision
SECONDARY	Frequency of Grade 3 and Higher Adverse Events for Phase II Subjects	From date of first dose until 30 days after the last treatment up to 1 year.	This study was terminated at Phase I due to funder's decision
SECONDARY	Mortality Rate at 3 and 6 Months for Phase II Subjects	From start of treatment up to 2 years or until death.	This study was terminated at Phase I due to funder's decision

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose(s) (RP2D)	Phase I: TAK-659 100mg + Ixazomid 2.3mg		NA		mg

Source ClinicalTrials.gov

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Study Treatment	STARTED	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	8
Study Treatment	STARTED	Phase I, Level 2: TAK-659 100mg + Ixazomid 3mg	0
Study Treatment	STARTED	Phase I, Level 3: TAK-659 100mg + Ixazomid 4mg	0
Study Treatment	STARTED	Phase II:TAK-659 100mg+ Ixazomib MTD	0
Study Treatment	COMPLETED	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	0
Study Treatment	COMPLETED	Phase I, Level 2: TAK-659 100mg + Ixazomid 3mg	0
Study Treatment	COMPLETED	Phase I, Level 3: TAK-659 100mg + Ixazomid 4mg	0
Study Treatment	COMPLETED	Phase II:TAK-659 100mg+ Ixazomib MTD	0
Study Treatment	NOT COMPLETED	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	8
Study Treatment	NOT COMPLETED	Phase I, Level 2: TAK-659 100mg + Ixazomid 3mg	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events61

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ADULT RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	1	7	1
other	ALANINE AMINOTRANSFERASE INCREASED	Investigations	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	1	7	1
other	ALKALINE PHOSPHATASE INCREASED	Investigations	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	1	7	1
other	ANEMIA	Blood and lymphatic system disorders	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	4	7	4
other	ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	2	7	2
other	BACK PAIN	Musculoskeletal and connective tissue disorders	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	1	7	1
other	BACTEREMIA	Infections and infestations	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	1	7	1
other	BLOOD AND LYMPHATIC SYSTEM DISORDERS	Blood and lymphatic system disorders	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	2	7	2
other	BLOOD BILIRUBIN INCREASED	Investigations	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	1	7	1
other	BONE PAIN	Musculoskeletal and connective tissue disorders	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	1	7	5

1 to 10 of 61Source ClinicalTrials.gov

See all 61 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	5	7
Total, other adverse events	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	7	7
Total, serious adverse events	Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg	5	7

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41748936	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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