Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

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Pancreatic Neoplasms

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Sarcoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Thymoma

Thymus Neoplasms

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Endocrine System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Thoracic Neoplasms

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Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Regorafenib 160 mg (40 mg tablets), po, every day for 3 weeks of every 4 week cycle

Regorafenib

Armando Santoro, MD

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.

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

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

to evaluate activity of regorafenib, in terms of 2-months progression free survival rate

to explore the prognosis in terms of progression-free survival calculated from the first day of regorafenib treatment to the date of tumor progression or death, whichever occurs first.

to explore overall survival (OS) measured from the first day of regorafenib treatment until the date of death from any cause or the date of the last contact, at which the patients will be censored

to assess the safety profile of regorafenib according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3

Istituto Clinico Humanitas

Spots Global Cancer Trial Database for thymoma type b2