NCT02048371 · OUTCOME

Overall Response Rate (ORR). All Cohorts.

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 overall response rate (ORR) is the percentage of patients whose cancer shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1

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

Cohort B: Osteosarcoma, Placebo

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

Cohort C: Ewing Sarcoma

Cohort D: Rhabdomyosarcoma

Cohort E: Mesenchymal Chondrosarcoma

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

Analysis denominator · Participants

Group	Source count
Cohort A: Liposarcoma	24
Cohort A: Liposarcoma, Placebo	24
Cohort B: Osteosarcoma	22
Cohort B: Osteosarcoma, Placebo	20
Cohort C: Ewing Sarcoma	30
Cohort D: Rhabdomyosarcoma	10
Cohort E: Mesenchymal Chondrosarcoma	1

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: Liposarcoma	0	Not reported	Not reported	Not reported	Not reported
Cohort A: Liposarcoma, Placebo	1	Not reported	Not reported	Not reported	Not reported
Cohort B: Osteosarcoma	3	Not reported	Not reported	Not reported	Not reported
Cohort B: Osteosarcoma, Placebo	0	Not reported	Not reported	Not reported	Not reported
Cohort C: Ewing Sarcoma	3	Not reported	Not reported	Not reported	Not reported
Cohort D: Rhabdomyosarcoma	0	Not reported	Not reported	Not reported	Not reported
Cohort E: Mesenchymal Chondrosarcoma	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
0
group Id
OG004
value
3
group Id
OG005
value
0
group Id
OG006
value
0

denoms

counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
22
group Id
OG003
value
20
group Id
OG004
value
30
group Id
OG005
value
10
group Id
OG006
value
1
units
Participants

description

groups

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
description
21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
id
OG001
title
Cohort A: Liposarcoma, Placebo
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
description
21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
id
OG003
title
Cohort B: Osteosarcoma, Placebo
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
OG004
title
Cohort C: Ewing Sarcoma
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
OG005
title
Cohort D: Rhabdomyosarcoma
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
OG006
title
Cohort E: Mesenchymal Chondrosarcoma

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

up to 3 years

title

Overall Response Rate (ORR). All Cohorts.

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice