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Phase II Study of Regorafenib as Maintenance Therapy

NCT03793361 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Metastatic Soft Tissue Sarcoma

Interventions

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

Sponsors & Collaborators

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Nicolas PENEL, PhD · Centre Oscar Lambret

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2024-03-15
Completion
2024-09-26

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03793361 on ClinicalTrials.gov