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NCT02186509 · OUTCOME

Maximum Tolerated Dose (MTD) of Alisertib

Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas · Source last updated 2025-04-30

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

Measure
NUMBER
Unit
mg dose of Alisertib
Interval / dispersion
Not reported
Time frame
Up to 30 days after completion of radiation therapy

What was measured

Defined as the dose at which \>= 2 patients experience dose-limiting toxicity, graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Groups in this outcome

Alisertib, Fractionated Stereotactic Radiosurgery

CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days. MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies

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

Analysis denominator · Participants

GroupSource count
Alisertib, Fractionated Stereotactic Radiosurgery17

Reported measurements

Source class 1
Values in mg dose of Alisertib · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib, Fractionated Stereotactic Radiosurgery50Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Defined as the dose at which \>= 2 patients experience dose-limiting toxicity, graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
groups
  1. description
    CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days. MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
    id
    OG000
    title
    Alisertib, Fractionated Stereotactic Radiosurgery
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 30 days after completion of radiation therapy
title
Maximum Tolerated Dose (MTD) of Alisertib
type
PRIMARY
unit Of Measure
mg dose of Alisertib

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

Preserved source evidence · Not medical advice