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NCT02048371 · OUTCOME

Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes · Source last updated 2023-11-07

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
up to 16 weeks

What was measured

The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort C (Ewing/Ewing-like sarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1.

Groups in this outcome

Cohort C: Ewing Sarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Cohort D: Rhabdomyosarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Cohort E: Mesenchymal Chondrosarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

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

Analysis denominator · Participants

GroupSource count
Cohort C: Ewing Sarcoma30
Cohort D: Rhabdomyosarcoma10
Cohort E: Mesenchymal Chondrosarcoma1

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort C: Ewing Sarcoma3.4Not reported1.73.7Not reported
Cohort D: Rhabdomyosarcoma1.82Not reported1.58NAThe upper limit of the CI is below the level of detection.
Cohort E: Mesenchymal ChondrosarcomaNANot reportedNANAThere is only one participant, so statistics cannot be calculated.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.7
        upper Limit
        3.7
        value
        3.4
      2. comment
        The upper limit of the CI is below the level of detection.
        group Id
        OG001
        lower Limit
        1.58
        upper Limit
        NA
        value
        1.82
      3. comment
        There is only one participant, so statistics cannot be calculated.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      1
    units
    Participants
description
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort C (Ewing/Ewing-like sarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1.
dispersion Type
95% Confidence Interval
groups
  1. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG000
    title
    Cohort C: Ewing Sarcoma
  2. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG001
    title
    Cohort D: Rhabdomyosarcoma
  3. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG002
    title
    Cohort E: Mesenchymal Chondrosarcoma
param Type
MEDIAN
reporting Status
POSTED
time Frame
up to 16 weeks
title
Progression-free Survival (PFS). Cohort C, Cohort D, and Cohort E
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice