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NCT00697346 · OUTCOME

Number of Participants With Polymorphisms in Aurora A Kinase

Study of MLN8237 in Participants With Advanced Hematological Malignancies · Source last updated 2019-05-31

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
Cycle 1 Day 1 predose

Analysis population: As per protocol amendment, no data was collected for polymorphisms in Aurora A Kinase.

Groups in this outcome

Alisertib

Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).

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

Analysis denominator · Participants

GroupSource count
Alisertib0

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
    units
    Participants
groups
  1. description
    Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
    id
    OG000
    title
    Alisertib
population Description
As per protocol amendment, no data was collected for polymorphisms in Aurora A Kinase.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 predose
title
Number of Participants With Polymorphisms in Aurora A Kinase
type
SECONDARY

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

Preserved source evidence · Not medical advice