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NCT02431260 · OUTCOME

Duration of Response (DOR)

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies · Source last updated 2019-06-14

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Baseline through end of study, up to 6 months

What was measured

Defined as the time from earliest date of disease response until earliest date of disease progression or death.

Analysis population: As a result of early termination of the study, there are no participants that are responders and therefore DOR was not achieved.

Groups in this outcome

Part 1 / Treatment Group A: 15 MG QD INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 22.5 MG QD INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 15 MG BID INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 30 MG QD INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 22.5 MG BID INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 20 MG BID INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329

Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.

Part 1 / Treatment Group B: 20 MG BID INCB054329

Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.

Part 2 / Treatment Group A: 20 MG BID INCB054329

Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.

Part 2 / Treatment Group C: 20 mg BID INCB054329

Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.

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

Analysis denominator · Participants

GroupSource count
Part 1 / Treatment Group A: 15 MG QD INCB0543290
Part 1 / Treatment Group A: 22.5 MG QD INCB0543290
Part 1 / Treatment Group A: 15 MG BID INCB0543290
Part 1 / Treatment Group A: 30 MG QD INCB0543290
Part 1 / Treatment Group A: 22.5 MG BID INCB0543290
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB0543290
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB0543290
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB0543290
Part 1 / Treatment Group A: 20 MG BID INCB0543290
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB0543290
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB0543290
Part 1 / Treatment Group B: 20 MG BID INCB0543290
Part 2 / Treatment Group A: 20 MG BID INCB0543290
Part 2 / Treatment Group C: 20 mg BID INCB0543290

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      0
    11. group Id
      OG010
      value
      0
    12. group Id
      OG011
      value
      0
    units
    Participants
description
Defined as the time from earliest date of disease response until earliest date of disease progression or death.
groups
  1. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG000
    title
    Part 1 / Treatment Group A: 15 MG QD INCB054329
  2. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG001
    title
    Part 1 / Treatment Group A: 22.5 MG QD INCB054329
  3. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG002
    title
    Part 1 / Treatment Group A: 15 MG BID INCB054329
  4. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG003
    title
    Part 1 / Treatment Group A: 30 MG QD INCB054329
  5. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG004
    title
    Part 1 / Treatment Group A: 22.5 MG BID INCB054329
  6. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG005
    title
    Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
  7. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG006
    title
    Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
  8. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG007
    title
    Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
  9. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG008
    title
    Part 1 / Treatment Group A: 20 MG BID INCB054329
  10. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG009
    title
    Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
  11. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    OG010
    title
    Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
  12. description
    Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
    id
    OG011
    title
    Part 1 / Treatment Group B: 20 MG BID INCB054329
population Description
As a result of early termination of the study, there are no participants that are responders and therefore DOR was not achieved.
reporting Status
POSTED
time Frame
Baseline through end of study, up to 6 months
title
Duration of Response (DOR)
type
SECONDARY

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

Preserved source evidence · Not medical advice