NCT02307500

Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy

An Open-label Phase II Study of Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, single-stage, phase II trial to evaluate the activity of Regorafenib in patients with metastatic solid tumors (pancreatic cancer, ovarian cancer, melanoma, sarcoma, thymoma (type B2 - B3) and thymic carcinoma, who have progressed after standard therapy.

Detailed description

Each tumour will be assessed by itself. Regorafenib 40 mg tablets will be used in the study. Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Subjects will continue on treatment until at least one of the following occurs (main criteria): * Progressive Disease (PD) by radiological assessments or clinical progression * Death * Unacceptable toxicity * Subject withdraws consent * Treating physician determines discontinuation of treatment is in the subject's best interest * Substantial non-compliance with the protocol

Conditions

• Pancreas Cancer
• Ovarian Cancer
• Melanoma
• Sarcoma
• Thymoma Type B3
• Thymoma Type B2
• Thymic Carcinoma

Interventions

Type	Name	Description
DRUG	Regorafenib	oral therapy

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-01
• Completion: 2020-08-01
• First posted: 2014-12-04
• Last updated: 2022-09-10

Locations

1 site across 1 country: Italy