Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04752163 · OUTCOME

Recommended Phase 2 Dose (RP2D) (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

This will be selected based upon the cumulative safety, efficacy and PK data at the end of the Phase 1 portion when the maximum tolerated dose is found. This will be One dose level below the RP2D of DS-1594b from Phase 1.

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

GroupSource count
Phase I (DS-1594b) Cohort 14
Phase I (DS-1594b) Cohort 24
Phase I (DS-1594b) Cohort 35
Phase I (DS-1594b) Cohort 43
Phase I (DS-1594b) Cohort 51
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
GroupValueSpreadLowerUpperComment
Phase I (DS-1594b) Cohort 1NANot reportedNot reportedNot reportedThe maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
Phase I (DS-1594b) Cohort 2NANot reportedNot reportedNot reportedThe maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
Phase I (DS-1594b) Cohort 3NANot reportedNot reportedNot reportedThe maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
Phase I (DS-1594b) Cohort 4NANot reportedNot reportedNot reportedThe maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
Phase I (DS-1594b) Cohort 5NANot reportedNot reportedNot reportedThe maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.
Complete source fields
classes
  1. categories
    1. measurements
      1. 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
      2. 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
      3. 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
      4. 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
      5. 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
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    units
    Participants
description
This will be selected based upon the cumulative safety, efficacy and PK data at the end of the Phase 1 portion when the maximum tolerated dose is found. This will be One dose level below the RP2D of DS-1594b from Phase 1.
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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)
  7. 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)
  8. 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
Recommended Phase 2 Dose (RP2D) (Phase I)
type
PRIMARY
unit Of Measure
Milligrams

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice