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Spots Global Cancer Trial Database for Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy

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Trial Identification

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

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

Study ID: NCT02307500

Interventions

Regorafenib

Study Description

Brief 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Istituto Clinico Humanitas, Rozzano, Milan, Italy

Contact Details

Name: Armando Santoro, MD

Affiliation: Istituto Clinico Humanitas

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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