NCT01900743

Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma

Activity and Safety of Regorafenib in Patients With Metastatic Soft Tissue Sarcoma Previously Treated With Anthracycline-based Chemotherapy : a Multinational, Randomized, Phase II, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The standard of care for metastatic soft tissue sarcoma is doxorubicin +/- ifosfamide. After failure or intolerance to doxorubicin, there is no standard of care. In Europe, two are currently approved for the treatment of soft tissue sarcoma after failure/intolerance to doxorubicin: trabectedin (Yondelis®) for all histological subtype and pazopanib (Votrient ®) for all subtypes excluding liposarcomas. Nevertheless, none of these drugs improve the overall survival over placebo. The study is composed of 3 periods: 1. A Screening Period, 2. A Treatment Period, 3. And a Survival Follow-up Period. Patients randomized to be treated with regorafenib will receive the treatment orally for 3 weeks of every 4 week (28 days) cycle (ie, 3 weeks on/1 week off). Patients randomized to the placebo arm will be treated for 3 weeks of every 4 weeks cycle (ie, 3 weeks on/1 week off). In addition to the regorafenib and placebo treatments, patients will receive best supportive care. Best supportive care includes any method to preserve the comfort and dignity of the patients and excludes any disease-specific anti-neoplastic therapy such as any kinase inhibitor,chemotherapy, radiation therapy, or surgical intervention. Patients receiving placebo, who experience disease progression may be offered open-label regorafenib(cross-over option).

Conditions

• Sarcoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-06-05
• Primary completion: 2020-09-16
• Completion: 2020-09-16
• First posted: 2013-07-16
• Last updated: 2026-03-13

Locations

25 sites across 2 countries: Austria, France