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NCT03323034 · OUTCOME

T Max of Pevonedistat in Combination With Irinotecan and Temozolomide

Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma · Source last updated 2024-10-22

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

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Up to 10 days

What was measured

Median (Range) for the time at which the maximum (peak) serum concentration occurs by dose level stratified by study part and dose level.

Analysis population: All eligible patients with data collected

Groups in this outcome

Part A Dose Level 1: 15 mg/m^2

Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

Part A Dose Level 2: 20 mg/m^2

Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

Part A Dose Level 3: 25 mg/m^2

Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

Part A Dose Level 4: 35 mg/m^2

Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

Part A PK Dose Level 4: 35 mg/m^2

Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

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 A Dose Level 1: 15 mg/m^25
Part A Dose Level 2: 20 mg/m^26
Part A Dose Level 3: 25 mg/m^26
Part A Dose Level 4: 35 mg/m^26
Part A PK Dose Level 4: 35 mg/m^26

Reported measurements

Source class 1
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A Dose Level 1: 15 mg/m^21.Not reported1.01.6Not reported
Part A Dose Level 2: 20 mg/m^21Not reported1.02.5Not reported
Part A Dose Level 3: 25 mg/m^21Not reported0.91.4Not reported
Part A Dose Level 4: 35 mg/m^21.1Not reported1.01.1Not reported
Part A PK Dose Level 4: 35 mg/m^21.1Not reported1.01.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        1.6
        value
        1.
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        2.5
        value
        1
      3. group Id
        OG002
        lower Limit
        0.9
        upper Limit
        1.4
        value
        1
      4. group Id
        OG003
        lower Limit
        1.0
        upper Limit
        1.1
        value
        1.1
      5. group Id
        OG004
        lower Limit
        1.0
        upper Limit
        1.5
        value
        1.1
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    units
    Participants
description
Median (Range) for the time at which the maximum (peak) serum concentration occurs by dose level stratified by study part and dose level.
dispersion Type
Full Range
groups
  1. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Part A Dose Level 1: 15 mg/m^2
  2. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Part A Dose Level 2: 20 mg/m^2
  3. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    OG002
    title
    Part A Dose Level 3: 25 mg/m^2
  4. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    OG003
    title
    Part A Dose Level 4: 35 mg/m^2
  5. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    OG004
    title
    Part A PK Dose Level 4: 35 mg/m^2
param Type
MEDIAN
population Description
All eligible patients with data collected
reporting Status
POSTED
time Frame
Up to 10 days
title
T Max of Pevonedistat in Combination With Irinotecan and Temozolomide
type
PRIMARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice