Last updated on May 2019

Phase II Study of Regorafenib as Maintenance Therapy


Brief description of study

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 Study 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

Clinical Study Identifier: NCT03793361

Find a site near you

Start Over