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NCT03372057 · OUTCOME

Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)

A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2025-03-07

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)

What was measured

Blood samples were taken for the analyses of duvelisib and IPI-656 in plasma at designated time points. Results are reported as nanograms/milliliter (ng/mL).

Analysis population: Safety Analysis Set: all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those who were evaluable for this outcome measure, and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.

Groups in this outcome

Dose Optimization Phase: Cohort 1

Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.

Dose Optimization Phase: Cohort 2

Duvelisib 75 mg PO BID, administered in 28-day cycles.

Expansion Phase

Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).

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

Analysis denominator · Participants

GroupSource count
Dose Optimization Phase: Cohort 114
Dose Optimization Phase: Cohort 212
Expansion Phase100

Reported measurements

Duvelisib: Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Dose Optimization Phase: Cohort 114
Dose Optimization Phase: Cohort 212
Expansion Phase100
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Optimization Phase: Cohort 11238.1787.53Not reportedNot reportedNot reported
Dose Optimization Phase: Cohort 22070.0889.39Not reportedNot reportedNot reported
Expansion Phase2873.71709.15Not reportedNot reportedNot reported
Duvelisib: Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Dose Optimization Phase: Cohort 14
Dose Optimization Phase: Cohort 20
Expansion Phase68
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Optimization Phase: Cohort 11492.51019.10Not reportedNot reportedNot reported
Expansion Phase2648.21336.94Not reportedNot reportedNot reported
Metabolite (IPI-156): Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Dose Optimization Phase: Cohort 114
Dose Optimization Phase: Cohort 212
Expansion Phase100
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Optimization Phase: Cohort 11310.41408.99Not reportedNot reportedNot reported
Dose Optimization Phase: Cohort 21580.9772.13Not reportedNot reportedNot reported
Expansion Phase2387.51919.33Not reportedNot reportedNot reported
Metabolite (IPI-156): Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Dose Optimization Phase: Cohort 14
Dose Optimization Phase: Cohort 20
Expansion Phase68
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Optimization Phase: Cohort 1894.8441.55Not reportedNot reportedNot reported
Expansion Phase2427.01655.89Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        787.53
        value
        1238.1
      2. group Id
        OG001
        spread
        889.39
        value
        2070.0
      3. group Id
        OG002
        spread
        1709.15
        value
        2873.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        100
      units
      Participants
    title
    Duvelisib: Cycle 1, Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1019.10
        value
        1492.5
      2. group Id
        OG002
        spread
        1336.94
        value
        2648.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        68
      units
      Participants
    title
    Duvelisib: Cycle 2, Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1408.99
        value
        1310.4
      2. group Id
        OG001
        spread
        772.13
        value
        1580.9
      3. group Id
        OG002
        spread
        1919.33
        value
        2387.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        100
      units
      Participants
    title
    Metabolite (IPI-156): Cycle 1, Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        441.55
        value
        894.8
      2. group Id
        OG002
        spread
        1655.89
        value
        2427.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        68
      units
      Participants
    title
    Metabolite (IPI-156): Cycle 2, Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      100
    units
    Participants
description
Blood samples were taken for the analyses of duvelisib and IPI-656 in plasma at designated time points. Results are reported as nanograms/milliliter (ng/mL).
dispersion Type
Standard Deviation
groups
  1. description
    Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
    id
    OG000
    title
    Dose Optimization Phase: Cohort 1
  2. description
    Duvelisib 75 mg PO BID, administered in 28-day cycles.
    id
    OG001
    title
    Dose Optimization Phase: Cohort 2
  3. description
    Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
    id
    OG002
    title
    Expansion Phase
param Type
MEAN
population Description
Safety Analysis Set: all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those who were evaluable for this outcome measure, and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
reporting Status
POSTED
time Frame
Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles)
title
Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice