NCT03793361

Phase II Study of Regorafenib as Maintenance Therapy

Efficacy of Regorafenib as Maintenance Therapy in Non-adipocytic Soft Tissue Sarcoma Having Received First-line Doxorubicin-based Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Regorafenib	Oral Drug in the form of 40 mg tablets - Regorafenib (120 mg/d) once daily for 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or consent withdrawal. Provided by BAYER
DRUG	Placebo	Oral tablets - Placebo plus BSC until progression (according to RECIST 1.1) or unacceptable toxicity. Patients who have received placebo may be offered open-label regorafenib (cross-over option) after objective tumor progression Provided by BAYER

Timeline

• Start date: 2019-05-15
• Primary completion: 2024-03-15
• Completion: 2024-09-26
• First posted: 2019-01-04
• Last updated: 2026-03-18

Locations

20 sites across 1 country: France