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A Single Arm, Open-label, Multicenter Phase 2 Study of Regorafenib in Participants Who Have Been Treated in a Previous Bayer-sponsored Regorafenib Study (Monotherapy or Combination Treatment) That Has Reached the Primary Completion Endpoint or the Main Data Analysis or Has Been Stopped Prematurely.
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: * How safe is the continued treatment with regorafenib in participants with solid tumors? * How well is the continued treatment with regorafenib tolerated by participants with solid tumors? 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.
Age
10 - No limit years
Sex
ALL
Healthy Volunteers
No
Hopital Claude Huriez - Lille
Lille, Hauts-de-France, France
Hôpital Beaujon - Clichy
Clichy, Île-de-France Region, France
Hôpital Paul Brousse - Villejuif
Villejuif, Île-de-France Region, France
Saitama Cancer Center
Kitaadachi-gun, Saitama, Japan
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Infantil Universitario Nino Jesus | Oncologia Pediatrica
Madrid, Spain
China Medical University Hospital
Taichung, Taiwan
Start Date
January 24, 2024
Primary Completion Date
April 27, 2028
Completion Date
April 27, 2028
Last Updated
March 19, 2026
13
ESTIMATED participants
Regorafenib (Stivarga, BAY73-4506)
DRUG
Lead Sponsor
Bayer
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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