A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies

NCT06246643 | Active Not Recruiting Phase 2

• 2 other identifiers: 225512023-507084-19-00
• Study Type: interventional
• Target: 13
• Locations: 5 countries
• Sites: 7

Brief Summary

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.

Conditions

Solid Malignant Tumors

Outcome Measures

Primary Outcomes (1)

• Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity

  through study completion, an average of 2.5 year

Secondary Outcomes (1)

• Number of participants with dose modifications

  through study completion, an average of 2.5 year

Study Arms (1)

Regorafenib

EXPERIMENTAL

Adult and pediatric patients from completed Bayer-sponsored regorafenib trials who are benefiting from regorafenib treatment.

Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

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).

Regorafenib

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving regorafenib as study treatment.
• Participant is currently benefiting from treatment with regorafenib monotherapy. All participants must meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
• Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.

You may not qualify if:

• Ineligibility, for medical reasons, to start the subsequent cycle in the respective feeder study.
• Participants with a beta-human chorionic gonadotropin (hCG) test result consistent with pregnancy.
• Participants are using one or more of the prohibited medications listed in the respective feeder study protocol.
• Participant has been previously permanently discontinued from regorafenib treatment.

Sponsors & Collaborators

• Bayer: lead

Study Sites (7)

Hopital Claude Huriez - Lille

Lille, Hauts-de-France, 59037, France

Location

Hôpital Beaujon - Clichy

Clichy, Île-de-France Region, 92110, France

Location

Hôpital Paul Brousse - Villejuif

Villejuif, Île-de-France Region, 94800, France

Location

Saitama Cancer Center

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 3080, South Korea

Location

Hospital Infantil Universitario Nino Jesus | Oncologia Pediatrica

Madrid, 28009, Spain

Location

China Medical University Hospital

Taichung, 404327, Taiwan

Location

MeSH Terms

Interventions

regorafenib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 7, 2024
• Study Start: January 24, 2024
• Primary Completion (Estimated): April 27, 2028
• Study Completion (Estimated): April 27, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); ES (1); TW (1); KR (1); JP (1)