Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02389244
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2015-02-09
Brief Title:
A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
A Randomized Phase II Placebo-controlled Multicenter Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REGOBONE
Brief Summary:
INDICATION
Metastatic bone sarcomas conventional high grade osteosarcoma Ewing sarcoma of bone intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas
Metastatic bone sarcomas conventional high grade osteosarcoma Ewing sarcoma of bone intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas
Detailed Description:
METHODOLOGY
Randomized placebo-controlled multicentric phase II study -This is a double-blind placebo-controlled trial with 5 cohorts cohort A Osteosarcoma cohort B Ewing sarcoma cohort C Chondrosarcoma cohort D chondroma cohort E CIC-rearranged sarcoma Cohort A B and C will involve a total of 36 patients 24 Regorafenib 12 placebo cohort D a total of 24 evaluable patients 16 Regorafenib 8 placebo and cohort E will involve a total of 27 evaluable patients 18 Regorafenib 9 placebo
159 patients who meet the eligibility criteria will be randomly assigned in a 21 ratio to the following treatment groups
The Arm A
Regorafenib 160 mgd once daily for the 3 weeks on 1 week off plus Best Supportive Care BSC until progression according to RECIST 11 intolerance or withdrawal of consent
Patients receiving regorafenib who experience disease progression and for whom in the investigator opinion treatment with regorafenib is providing clinical benefit may continue the treatment following consultation with the study coordinator and the sponsor
The Arm B
Placebo plus BSC until progression according to RECIST V11 intolerance or withdrawal of consent Patients who have received placebo will receive open-label regorafenib after objective tumor progression
Patients will be stratified at randomization according to histology
Randomized placebo-controlled multicentric phase II study -This is a double-blind placebo-controlled trial with 5 cohorts cohort A Osteosarcoma cohort B Ewing sarcoma cohort C Chondrosarcoma cohort D chondroma cohort E CIC-rearranged sarcoma Cohort A B and C will involve a total of 36 patients 24 Regorafenib 12 placebo cohort D a total of 24 evaluable patients 16 Regorafenib 8 placebo and cohort E will involve a total of 27 evaluable patients 18 Regorafenib 9 placebo
159 patients who meet the eligibility criteria will be randomly assigned in a 21 ratio to the following treatment groups
The Arm A
Regorafenib 160 mgd once daily for the 3 weeks on 1 week off plus Best Supportive Care BSC until progression according to RECIST 11 intolerance or withdrawal of consent
Patients receiving regorafenib who experience disease progression and for whom in the investigator opinion treatment with regorafenib is providing clinical benefit may continue the treatment following consultation with the study coordinator and the sponsor
The Arm B
Placebo plus BSC until progression according to RECIST V11 intolerance or withdrawal of consent Patients who have received placebo will receive open-label regorafenib after objective tumor progression
Patients will be stratified at randomization according to histology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-003910-42 | EUDRACT_NUMBER | None | None |