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NCT01532687 · OUTCOME

Progression-free Survival (PFS) for a Sub-group of Patients Treated With Open-label Pazopanib Hydrochloride Following Administration of Gemcitabine Hydrochloride in the Cross-over Portion of This Study

Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma · Source last updated 2021-09-27

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
Calculated as the time from receiving open-labeled pazopanib hydrochloride to the next documented progression or death whichever occurs first, assessed up to 3 years

What was measured

Participants who progress during treatment and are found to be part of the gemcitabine+placebo arm after unblinding are eligible to receive open-label pazopanib with gemcitabine. This is the crossover population. Statistical analysis is exploratory and requires sufficient crossover participants to assess Kaplan-Meier estimated hazard ratio and associated 95% confidence interval. This represents the participants second progression. In both cases progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions with an absolute increase of at least 5 mm (target lesions), or measurable increase in non-target lesions (unequivocal progression), or appearance of one or more new lesions. First progression uses the smallest sum on study as a reference; progression for the crossover population uses first progression measurements as the reference.

Analysis population: Participants randomized to the gemcitabine + placebo arm who progressed and elected to receive gemcitibine + open-label pazopanib

Groups in this outcome

Crossover From Gemcitabine + Placebo to Gemcitabine + Open-label Pazopanib

Participants randomized to the gemcitabine + placebo arm who progressed can be moved into the crossover arm, receiving gemcitabine + open-label pazopanib

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

Analysis denominator · Participants

GroupSource count
Crossover From Gemcitabine + Placebo to Gemcitabine + Open-label Pazopanib14

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Crossover From Gemcitabine + Placebo to Gemcitabine + Open-label Pazopanib3.0Not reported1.3NADue to the small sample size (n = 14) the upper confidence limit was not estimable (did not cross the 50% line)
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Due to the small sample size (n = 14) the upper confidence limit was not estimable (did not cross the 50% line)
        group Id
        OG000
        lower Limit
        1.3
        upper Limit
        NA
        value
        3.0
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Participants who progress during treatment and are found to be part of the gemcitabine+placebo arm after unblinding are eligible to receive open-label pazopanib with gemcitabine. This is the crossover population. Statistical analysis is exploratory and requires sufficient crossover participants to assess Kaplan-Meier estimated hazard ratio and associated 95% confidence interval. This represents the participants second progression. In both cases progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions with an absolute increase of at least 5 mm (target lesions), or measurable increase in non-target lesions (unequivocal progression), or appearance of one or more new lesions. First progression uses the smallest sum on study as a reference; progression for the crossover population uses first progression measurements as the reference.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants randomized to the gemcitabine + placebo arm who progressed can be moved into the crossover arm, receiving gemcitabine + open-label pazopanib
    id
    OG000
    title
    Crossover From Gemcitabine + Placebo to Gemcitabine + Open-label Pazopanib
param Type
MEDIAN
population Description
Participants randomized to the gemcitabine + placebo arm who progressed and elected to receive gemcitibine + open-label pazopanib
reporting Status
POSTED
time Frame
Calculated as the time from receiving open-labeled pazopanib hydrochloride to the next documented progression or death whichever occurs first, assessed up to 3 years
title
Progression-free Survival (PFS) for a Sub-group of Patients Treated With Open-label Pazopanib Hydrochloride Following Administration of Gemcitabine Hydrochloride in the Cross-over Portion of This Study
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice