Phase II Study of Regorafenib as Maintenance Therapy

Status Suspended

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03793361
Study type	Interventional
Source	Centre Oscar Lambret
Contact
Status	Suspended
Phase	Phase 2
Start date	May 15, 2019
Completion date	March 2025

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