Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04145700 · OUTCOME

Progression Free Survival (PFS)

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma · Source last updated 2023-09-13

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
80% Confidence Interval
Time frame
Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months)

What was measured

PFS is defined as the time from randomization until the first investigator-determined objective progression as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause in the absence of progressive disease. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment or date of randomization, whichever is later.

Analysis population: All randomized participants (including the censored participants). Number of participants censored in Ramucirumab + Gemcitabine + Docetaxel=4, Gemcitabine + Docetaxel=2.

Groups in this outcome

Ramucirumab + Gemcitabine + Docetaxel

Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

Gemcitabine + Docetaxel

Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

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

Analysis denominator · Participants

GroupSource count
Ramucirumab + Gemcitabine + Docetaxel16
Gemcitabine + Docetaxel7

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
Ramucirumab + Gemcitabine + Docetaxel2.10Not reported26Not reported
Gemcitabine + Docetaxel2.03Not reported1.38NAThere were not enough events to estimate the upper confidence limit.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    80
    ci Upper Limit
    4.46
    group Description
    To conclude success for the intervention, the Bayesian analysis must yield a minimum of 99% posterior probability for PFS Hazard ratio less than 1 \[i.e., Pr(HR \< 1) \> 99%\]. The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.051
    param Type
    Posterior Mean Hazard Ratio
    param Value
    2.62
    statistical Method
    Bayesian hierarchical model
Complete source fields
analyses
  1. ci Lower Limit
    1.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    80
    ci Upper Limit
    4.46
    group Description
    To conclude success for the intervention, the Bayesian analysis must yield a minimum of 99% posterior probability for PFS Hazard ratio less than 1 \[i.e., Pr(HR \< 1) \> 99%\]. The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.051
    param Type
    Posterior Mean Hazard Ratio
    param Value
    2.62
    statistical Method
    Bayesian hierarchical model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        6
        value
        2.10
      2. comment
        There were not enough events to estimate the upper confidence limit.
        group Id
        OG001
        lower Limit
        1.38
        upper Limit
        NA
        value
        2.03
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      7
    units
    Participants
description
PFS is defined as the time from randomization until the first investigator-determined objective progression as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause in the absence of progressive disease. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment or date of randomization, whichever is later.
dispersion Type
80% Confidence Interval
groups
  1. description
    Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
    id
    OG000
    title
    Ramucirumab + Gemcitabine + Docetaxel
  2. description
    Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
    id
    OG001
    title
    Gemcitabine + Docetaxel
param Type
MEDIAN
population Description
All randomized participants (including the censored participants). Number of participants censored in Ramucirumab + Gemcitabine + Docetaxel=4, Gemcitabine + Docetaxel=2.
reporting Status
POSTED
time Frame
Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months)
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice