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Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma

NCT01900743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2026-03-13

No results posted yet for this study

Summary

This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline).

Five cohorts will be defined:

Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups.

Conditions

  • Sarcoma

Interventions

DRUG

Regorafenib

Regorafenib (160 mg/d) once daily for three weeks on / one week off plus Best Supportive Care (BSC)until progression (according to RECIST 1.1), intolerance or consent withdrawal.

DRUG

Placebo

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

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Nicolas PENEL, PhD · Centre Oscar Lambret - France

  • Thomas BRODOWICZ, PhD · AKH-Wien - Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-05
Primary Completion
2020-09-16
Completion
2020-09-16

Countries

  • Austria
  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01900743 on ClinicalTrials.gov