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NCT02048371 · OUTCOME

Progression-free Survival (PFS). Cohort A and Cohort B

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 3 years

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 A (liposarcoma) and Cohort B (osteosarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, where a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Groups in this outcome

Cohort A: Liposarcoma

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 A: Liposarcoma, Placebo

21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off

Cohort B: Osteosarcoma

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 B: Osteosarcoma, Placebo

21 days on and 7 days off Placebo Placebo: 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 A: Liposarcoma24
Cohort A: Liposarcoma, Placebo24
Cohort B: Osteosarcoma22
Cohort B: Osteosarcoma, Placebo20

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A: Liposarcoma1.87Not reported0.923.67Not reported
Cohort A: Liposarcoma, Placebo2.07Not reported1.643.44Not reported
Cohort B: Osteosarcoma3.6Not reported2.07.6Not reported
Cohort B: Osteosarcoma, Placebo1.7Not reported1.21.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.92
        upper Limit
        3.67
        value
        1.87
      2. group Id
        OG001
        lower Limit
        1.64
        upper Limit
        3.44
        value
        2.07
      3. group Id
        OG002
        lower Limit
        2.0
        upper Limit
        7.6
        value
        3.6
      4. group Id
        OG003
        lower Limit
        1.2
        upper Limit
        1.8
        value
        1.7
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      24
    3. group Id
      OG002
      value
      22
    4. group Id
      OG003
      value
      20
    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 A (liposarcoma) and Cohort B (osteosarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, where a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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 A: Liposarcoma
  2. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    OG001
    title
    Cohort A: Liposarcoma, Placebo
  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 B: Osteosarcoma
  4. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    OG003
    title
    Cohort B: Osteosarcoma, Placebo
param Type
MEDIAN
reporting Status
POSTED
time Frame
up to 3 years
title
Progression-free Survival (PFS). Cohort A and Cohort B
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice