Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT03793361
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2018-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Regorafenib as Maintenance Therapy
Sponsor:
Centre Oscar Lambret
Organization:
Study Overview
Official Title:
Efficacy of Regorafenib as Maintenance Therapy in Non-adipocytic Soft Tissue Sarcoma Having Received First-line Doxorubicin-based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy.
Detailed Description:
Patients will be randomized 1:1 using a centralized randomization software, assuring concealment, with a minimization program controlling for the following factors:
* Histological subgroups: leiomyosarcoma versus synovial sarcoma versus other histological subtype
* Response to doxorubicin-based chemotherapy: partial response versus stable disease
* Centers
The treatment will be administrated as long as it appears beneficial. Evaluations will be made every 8 weeks until 6 months and then every 3 months
* Histological subgroups: leiomyosarcoma versus synovial sarcoma versus other histological subtype
* Response to doxorubicin-based chemotherapy: partial response versus stable disease
* Centers
The treatment will be administrated as long as it appears beneficial. Evaluations will be made every 8 weeks until 6 months and then every 3 months
Study Oversight
Has Oversight DMC:
True
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?: