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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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regorafenib | Experimental | Regorafenib 160 mg (40 mg tablets), po, every day for 3 weeks of every 4 week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib | Drug | oral therapy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| activity of regorafenib screening, in terms of 2-months progression free survival rate | to evaluate activity of regorafenib, in terms of 2-months progression free survival rate | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| prognosis in terms of progression-free survival | 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. | 36 months |
| overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armando Santoro, MD | Istituto Clinico Humanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico Humanitas | Rozzano | Milan | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21170960 | Background | Wilhelm SM, Dumas J, Adnane L, Lynch M, Carter CA, Schutz G, Thierauch KH, Zopf D. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer. 2011 Jul 1;129(1):245-55. doi: 10.1002/ijc.25864. Epub 2011 Apr 22. | |
| 11001068 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D008545 | Melanoma |
| D012509 | Sarcoma |
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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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 |
| 36 months |
| safety profile of regorafenib according to NCI-CTC v.3 | to assess the safety profile of regorafenib according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3 | 3 months |
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| 32590747 | Derived | Marrari A, Bertuzzi A, Bozzarelli S, Gennaro N, Giordano L, Quagliuolo V, De Sanctis R, Sala S, Balzarini L, Santoro A. Activity of regorafenib in advanced pretreated soft tissue sarcoma: Results of a single-center phase II study. Medicine (Baltimore). 2020 Jun 26;99(26):e20719. doi: 10.1097/MD.0000000000020719. |
| 31746632 | Derived | Bozzarelli S, Rimassa L, Giordano L, Sala S, Tronconi MC, Pressiani T, Smiroldo V, Prete MG, Spaggiari P, Personeni N, Santoro A. Regorafenib in patients with refractory metastatic pancreatic cancer: a Phase II study (RESOUND). Future Oncol. 2019 Dec;15(35):4009-4017. doi: 10.2217/fon-2019-0480. Epub 2019 Nov 20. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |