Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02601209 · OUTCOME

Overall Survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period)

Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma · Source last updated 2022-08-23

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years

What was measured

Overall survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period). Kaplan-Meier methodology will be used to estimate the distribution of OS.

Analysis population: Phase II Analysis Group 2 - Initial Treatment Period

Groups in this outcome

Phase II - Analysis Group 2 MLN0128

Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.

Phase II - Analysis Group 2 Pazopanib

Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.

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

Analysis denominator · Participants

GroupSource count
Phase II - Analysis Group 2 MLN012856
Phase II - Analysis Group 2 Pazopanib58

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II - Analysis Group 2 MLN012812.2Not reported7.516.3Not reported
Phase II - Analysis Group 2 Pazopanib13.7Not reported10.3NAThe 95% confidence interval upper limit was not estimable (i.e. insufficient number of participants with events).
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.5
        upper Limit
        16.3
        value
        12.2
      2. comment
        The 95% confidence interval upper limit was not estimable (i.e. insufficient number of participants with events).
        group Id
        OG001
        lower Limit
        10.3
        upper Limit
        NA
        value
        13.7
denoms
  1. counts
    1. group Id
      OG000
      value
      56
    2. group Id
      OG001
      value
      58
    units
    Participants
description
Overall survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period). Kaplan-Meier methodology will be used to estimate the distribution of OS.
dispersion Type
95% Confidence Interval
groups
  1. description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
    id
    OG000
    title
    Phase II - Analysis Group 2 MLN0128
  2. description
    Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
    id
    OG001
    title
    Phase II - Analysis Group 2 Pazopanib
param Type
MEDIAN
population Description
Phase II Analysis Group 2 - Initial Treatment Period
reporting Status
POSTED
time Frame
Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years
title
Overall Survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice