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

Solid Malignant Tumors Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06246643
• Other study ID #: 22551
• Secondary ID: 2023-507084-19-0
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 24, 2024
• Est. completion date: April 27, 2026

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: April 27, 2026
• Est. primary completion date: April 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Malignant Tumors

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
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).

Locations

Country	Name	City	State
France	Hôpital Beaujon - Clichy	Clichy
France	Hôpital Claude Huriez - Lille	Lille
France	Hôpital Paul Brousse - Villejuif	Villejuif
Japan	Saitama Cancer Center	Kitaadachi-gun	Saitama
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Spain	Hospital Infantil Universitario Nino Jesus | Unidad de Ensayos Clinicos - Pediatric Oncology Department	Madrid
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

France,  Japan,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with dose modifications		through study completion, an average of 2.5 year

External Links

•   Click here to find further information and, after study completion, the study results according to Bayer's transparency standards