NCT04752163 · OUTCOME

Maximum Tolerated Dose (MTD) (Phase I)

DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia · Source last updated 2025-05-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Milligrams
Interval / dispersion: Not reported
Time frame: Day 28

What was measured

The highest dose of DS-1594b treatment that does not cause unacceptable side effects.

Analysis population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Groups in this outcome

Phase I (DS-1594b) Cohort 1

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO

Phase I (DS-1594b) Cohort 2

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO

Phase I (DS-1594b) Cohort 3

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO

Phase I (DS-1594b) Cohort 4

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO

Phase I (DS-1594b) Cohort 5

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO

Phase 2 Cohort A and B (DS-1594b)

Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO

Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)

Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO

Phase 2 Cohort D (DS-1594b, Mini-HCVD)

Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Phase I (DS-1594b) Cohort 1	4
Phase I (DS-1594b) Cohort 2	4
Phase I (DS-1594b) Cohort 3	5
Phase I (DS-1594b) Cohort 4	3
Phase I (DS-1594b) Cohort 5	1
Phase 2 Cohort A and B (DS-1594b)	0
Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)	0
Phase 2 Cohort D (DS-1594b, Mini-HCVD)	0

Reported measurements

Source class 1

Values in Milligrams · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I (DS-1594b) Cohort 1	NA	Not reported	Not reported	Not reported	The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
Phase I (DS-1594b) Cohort 2	NA	Not reported	Not reported	Not reported	The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
Phase I (DS-1594b) Cohort 3	NA	Not reported	Not reported	Not reported	The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
Phase I (DS-1594b) Cohort 4	NA	Not reported	Not reported	Not reported	The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
Phase I (DS-1594b) Cohort 5	NA	Not reported	Not reported	Not reported	The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.

Complete source fields

classes

categories
measurements
comment
The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
group Id
OG000
value
NA
comment
The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
group Id
OG001
value
NA
comment
The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
group Id
OG002
value
NA
comment
The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
group Id
OG003
value
NA
comment
The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
group Id
OG004
value
NA

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
4
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
units
Participants

description

The highest dose of DS-1594b treatment that does not cause unacceptable side effects.

groups

description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO
id
OG000
title
Phase I (DS-1594b) Cohort 1
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO
id
OG001
title
Phase I (DS-1594b) Cohort 2
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO
id
OG002
title
Phase I (DS-1594b) Cohort 3
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO
id
OG003
title
Phase I (DS-1594b) Cohort 4
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO
id
OG004
title
Phase I (DS-1594b) Cohort 5
description
Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO
id
OG005
title
Phase 2 Cohort A and B (DS-1594b)
description
Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO
id
OG006
title
Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)
description
Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
id
OG007
title
Phase 2 Cohort D (DS-1594b, Mini-HCVD)

param Type

NUMBER

population Description

Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

reporting Status

POSTED

time Frame

Day 28

title

Maximum Tolerated Dose (MTD) (Phase I)

type

PRIMARY

unit Of Measure

Milligrams

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Preserved source evidence · Not medical advice