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NCT02142803 · OUTCOME

Most Common Related Toxicities That Led to Dose Hold/Reductions

TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors · Source last updated 2026-08-28

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 2 years

What was measured

Most common related toxicities that led to dose hold/reductions (AEs graded according to NCI CTCAE version 4.0). Safety assessed through summaries of adverse events, changes in selected laboratory test results, changes in vital signs, and TORC1/2 inhibitor MLN0128 and bevacizumab exposure.

Analysis population: AEs on the study are reported by dose level.

Groups in this outcome

Dose Level 1 - 3 mg MLN0128 Daily

Stage 1 - Dose Level 1 participants: * 3 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks

Dose Level 2 - 4 mg MLN0128 Daily

Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks

Dose Level 3 - 5 mg MLN0128 Daily

Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks

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 Level 1 - 3 mg MLN0128 Daily3
Dose Level 2 - 4 mg MLN0128 Daily3
Dose Level 3 - 5 mg MLN0128 Daily43

Reported measurements

Grade 3 Altered mental status
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily2Not reportedNot reportedNot reportedNot reported
Grade 3 Colon obstruction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 3 Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 3 Fatigue
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily3Not reportedNot reportedNot reportedNot reported
Grade 3 Hypercholesterolemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily2Not reportedNot reportedNot reportedNot reported
Grade 3 Hypokalemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily2Not reportedNot reportedNot reportedNot reported
Grade 3 Hypophosphatemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 3 Lymphopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 3 Oral mucositis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily5Not reportedNot reportedNot reportedNot reported
Grade 3 Pruritus
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily3Not reportedNot reportedNot reportedNot reported
Grade 3 Rash
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily10Not reportedNot reportedNot reportedNot reported
Grade 3 Thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 3 Vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 1/2 Abdominal pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily2Not reportedNot reportedNot reportedNot reported
Grade 1/2 Acute kidney injury
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily2Not reportedNot reportedNot reportedNot reported
Grade 1/2 Anorexia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily2Not reportedNot reportedNot reportedNot reported
Grade 1/2 Constipation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily2Not reportedNot reportedNot reportedNot reported
Grade 1/2 Dehydration
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily3Not reportedNot reportedNot reportedNot reported
Grade 1/2 Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily5Not reportedNot reportedNot reportedNot reported
Grade 1/2 Fatigue
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily8Not reportedNot reportedNot reportedNot reported
Grade 1/2 Fever
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 1/2 Hyperglycemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 1/2 Hypertriglyceridemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 1/2 Lymphopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 1/2 Nausea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily3Not reportedNot reportedNot reportedNot reported
Grade 1/2 Oral mucositis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily4Not reportedNot reportedNot reportedNot reported
Grade 1/2 Pruritis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily6Not reportedNot reportedNot reportedNot reported
Grade 1/2 Pulmonary emboli
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Grade 1/2 Rash
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily11Not reportedNot reportedNot reportedNot reported
Grade 1/2 Thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily6Not reportedNot reportedNot reportedNot reported
Grade 1/2 Vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 - 3 mg MLN0128 Daily1Not reportedNot reportedNot reportedNot reported
Dose Level 2 - 4 mg MLN0128 Daily0Not reportedNot reportedNot reportedNot reported
Dose Level 3 - 5 mg MLN0128 Daily0Not 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
        2
    title
    Grade 3 Altered mental status
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 3 Colon obstruction
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 3 Diarrhea
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
    title
    Grade 3 Fatigue
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Grade 3 Hypercholesterolemia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
    title
    Grade 3 Hypokalemia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 3 Hypophosphatemia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 3 Lymphopenia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5
    title
    Grade 3 Oral mucositis
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
    title
    Grade 3 Pruritus
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        10
    title
    Grade 3 Rash
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 3 Thrombocytopenia
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      43
    units
    Participants
description
Most common related toxicities that led to dose hold/reductions (AEs graded according to NCI CTCAE version 4.0). Safety assessed through summaries of adverse events, changes in selected laboratory test results, changes in vital signs, and TORC1/2 inhibitor MLN0128 and bevacizumab exposure.
groups
  1. description
    Stage 1 - Dose Level 1 participants: * 3 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
    id
    OG000
    title
    Dose Level 1 - 3 mg MLN0128 Daily
  2. description
    Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
    id
    OG001
    title
    Dose Level 2 - 4 mg MLN0128 Daily
  3. description
    Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
    id
    OG002
    title
    Dose Level 3 - 5 mg MLN0128 Daily
param Type
NUMBER
population Description
AEs on the study are reported by dose level.
reporting Status
POSTED
time Frame
Up to 2 years
title
Most Common Related Toxicities That Led to Dose Hold/Reductions
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice