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NCT02048371 · OUTCOME

Response Rate (RR), Cohorts A and B, After Crossover.

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 3 years

What was measured

The response rate (RR) is the percentage of patients whose cancer shrinks or disappears after treatment.

Analysis population: Participants who started on placebo then crossed over to active drug.

Groups in this outcome

Cohort A: Liposarcoma Crossover

Participants who crossed over to active drug after placebo. 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 Crossover

Participants who crossed over to active drug after placebo. 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 A: Liposarcoma Crossover15
Cohort B: Osteosarcoma Crossover11

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Liposarcoma Crossover0Not reportedNot reportedNot reportedNot reported
Cohort B: Osteosarcoma Crossover0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      11
    units
    Participants
description
The response rate (RR) is the percentage of patients whose cancer shrinks or disappears after treatment.
groups
  1. description
    Participants who crossed over to active drug after placebo. 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 Crossover
  2. description
    Participants who crossed over to active drug after placebo. 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 B: Osteosarcoma Crossover
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who started on placebo then crossed over to active drug.
reporting Status
POSTED
time Frame
up to 3 years
title
Response Rate (RR), Cohorts A and B, After Crossover.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice