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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507084-19-00 | Registry Identifier | CTIS (EU) |
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Regorafenib is an anti-cancer drug that blocks several proteins which are involved in the growth of cancer. It has been approved for different types of cancers of the digestive system and is being tested for use in some other solid tumors. Cancers that start in an organ, a muscle, or a bone form a solid tumor.
This study is for participants with solid tumors who have been taking regorafenib in other Bayer studies. They can continue taking regorafenib if it is working when treatment with regorafenib in their previous study ends.
The main purpose of this study is to find:
Participants will continue with the same dose of regorafenib that they were taking in their previous study as long as the treatment works for them/they want to continue the treatment/other medical conditions do not prevent them from participating in the study. For participants that are under 18 years of age, regorafenib tablets will be taken by mouth once daily for 2 weeks and repeat again after a 1-week gap. For participants that are over 18 years of age, regorafenib tablets will be taken by mouth once daily for 3 weeks and repeat again after a 1-week gap.
At the start of the study, researchers will review participants' records from the previous study. During the study, researchers will use blood samples and X-rays taken from participants under the age of 18 years to check how safe regorafenib is for children. They will also monitor any medical problems that participants may have during the study. After the last dose, follow-up will be done either within 14 days when participants visit their study doctor or within 30-35 days by phone call.
Both the researchers and the participants will know the dose of regorafenib the participants receive during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regorafenib | Experimental | Adult and pediatric patients from completed Bayer-sponsored regorafenib trials who are benefiting from regorafenib treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Participants will be treated with the regorafenib dose taken during the last cycle of the feeder study. Adult participants will receive either 60, 80, 90, 120, or 160 mg orally (p.o.) once daily (qd) for 3 weeks of every 4-week cycle (i.e. 3 weeks on, 1 week off). Pediatric participants will receive 82 mg/m^2 p.o. qd for 14 days, in a 14 days on/7 days off schedule (21-day cycle). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity | through study completion, an average of 2.5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose modifications | through study completion, an average of 2.5 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Claude Huriez - Lille | Lille | Hauts-de-France | 59037 | France | ||
| Hôpital Beaujon - Clichy |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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|
| Clichy |
| Île-de-France Region |
| 92110 |
| France |
| Hôpital Paul Brousse - Villejuif | Villejuif | Île-de-France Region | 94800 | France |
| Saitama Cancer Center | Kitaadachi | Saitama | 362-0806 | Japan |
| Seoul National University Hospital (SNUH) - Medical Oncology Center | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Hospital Infantil Universitario Nino Jesus | Oncologia Pediatrica | Madrid | 28009 | Spain |
| China Medical University Hospital | Taichung | 404327 | Taiwan |
| ID | Term |
|---|---|
| C559147 | regorafenib |
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