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NCT04209465 · OUTCOME

Phase 1: Incidence of Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of BDTX-189

A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. · Source last updated 2025-04-17

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Cycle 1 Day 1 (each cycle is 21 days) until 30 days post last dose

What was measured

Adverse events will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Groups in this outcome

25 mg QD

Patients who received doses at 25 mg once daily under fasted conditions.

50 mg QD

Patients who received doses at 50 mg once daily under fasted conditions.

100 mg QD

Patients who received doses at 100 mg once daily under fasted conditions.

200 mg QD

Patients who received doses at 200 mg once daily under fasted conditions.

400 mg QD

Patients dosed at 400 mg once daily under fasted conditions

800 mg QD Fasted

Patients enrolled at 800 mg once daily under fasted conditions

800 mg QD Not Fasted

Patients enrolled at 800 mg once daily under not fasted conditions

1000 mg QD

Patients enrolled at 1000 mg once daily under not fasted conditions

1200 mg QD

Patients enrolled at 1200 mg once daily under fasted conditions

400 mg BID

Patients enrolled at 400 mg twice daily under not fasted conditions

600 mg BID

Patients enrolled at 600 mg twice daily under not fasted conditions

800 mg BID

Patients enrolled at 800 mg twice daily under fasted conditions

Safety Expansion Set 800 mg QD

Safety expansion group patients enrolled at 800 mg once daily under not fasted conditions.

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

Analysis denominator · Participants

GroupSource count
25 mg QD1
50 mg QD1
100 mg QD1
200 mg QD2
400 mg QD10
800 mg QD Fasted18
800 mg QD Not Fasted13
1000 mg QD7
1200 mg QD6
400 mg BID4
600 mg BID6
800 mg BID5
Safety Expansion Set 800 mg QD17

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
25 mg QD0Not reportedNot reportedNot reportedNot reported
50 mg QD0Not reportedNot reportedNot reportedNot reported
100 mg QD0Not reportedNot reportedNot reportedNot reported
200 mg QD2Not reportedNot reportedNot reportedNot reported
400 mg QD10Not reportedNot reportedNot reportedNot reported
800 mg QD Fasted18Not reportedNot reportedNot reportedNot reported
800 mg QD Not Fasted13Not reportedNot reportedNot reportedNot reported
1000 mg QD7Not reportedNot reportedNot reportedNot reported
1200 mg QD6Not reportedNot reportedNot reportedNot reported
400 mg BID4Not reportedNot reportedNot reportedNot reported
600 mg BID6Not reportedNot reportedNot reportedNot reported
800 mg BID5Not reportedNot reportedNot reportedNot reported
Safety Expansion Set 800 mg QD17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        10
      6. group Id
        OG005
        value
        18
      7. group Id
        OG006
        value
        13
      8. group Id
        OG007
        value
        7
      9. group Id
        OG008
        value
        6
      10. group Id
        OG009
        value
        4
      11. group Id
        OG010
        value
        6
      12. group Id
        OG011
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      18
    7. group Id
      OG006
      value
      13
    8. group Id
      OG007
      value
      7
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      4
    11. group Id
      OG010
      value
      6
    12. group Id
      OG011
      value
      5
    units
    Participants
description
Adverse events will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.
groups
  1. description
    Patients who received doses at 25 mg once daily under fasted conditions.
    id
    OG000
    title
    25 mg QD
  2. description
    Patients who received doses at 50 mg once daily under fasted conditions.
    id
    OG001
    title
    50 mg QD
  3. description
    Patients who received doses at 100 mg once daily under fasted conditions.
    id
    OG002
    title
    100 mg QD
  4. description
    Patients who received doses at 200 mg once daily under fasted conditions.
    id
    OG003
    title
    200 mg QD
  5. description
    Patients dosed at 400 mg once daily under fasted conditions
    id
    OG004
    title
    400 mg QD
  6. description
    Patients enrolled at 800 mg once daily under fasted conditions
    id
    OG005
    title
    800 mg QD Fasted
  7. description
    Patients enrolled at 800 mg once daily under not fasted conditions
    id
    OG006
    title
    800 mg QD Not Fasted
  8. description
    Patients enrolled at 1000 mg once daily under not fasted conditions
    id
    OG007
    title
    1000 mg QD
  9. description
    Patients enrolled at 1200 mg once daily under fasted conditions
    id
    OG008
    title
    1200 mg QD
  10. description
    Patients enrolled at 400 mg twice daily under not fasted conditions
    id
    OG009
    title
    400 mg BID
  11. description
    Patients enrolled at 600 mg twice daily under not fasted conditions
    id
    OG010
    title
    600 mg BID
  12. description
    Patients enrolled at 800 mg twice daily under fasted conditions
    id
    OG011
    title
    800 mg BID
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From Cycle 1 Day 1 (each cycle is 21 days) until 30 days post last dose
title
Phase 1: Incidence of Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of BDTX-189
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice