do_not_disturb_altRecruitment Complete

Solid malignant tumors

Bayer Identifier:

22551

ClinicalTrials.gov Identifier:

NCT06246643

EudraCT Number:

Not Available

EU CT Number:

2023-507084-19-00​
A study of continued treatment with regorafenib in participants with solid tumors who have participated in other Bayer studies

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

10 - N/A
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
13
Trial Dates
January 2024 - April 2026
Phase
Phase 2
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Belle Vue ClinicKolkata, 700017, India
Active, not recruiting
Hôpital Paul Brousse - VillejuifVILLEJUIF, 94800, France
Active, not recruiting
Hopital Claude Huriez - LilleLILLE, 59037, France
Completed
Hôpital Beaujon - ClichyCLICHY, 92110, France
Withdrawn
Institut Bergonie - Unicancer Nouvelle AquitaineBordeaux, 33076, France
Active, not recruiting
Seoul National University HospitalSeoul, 3080, Korea,_republic_of
Completed
Hospital Infantil Universitario Nino Jesus | Unidad de Ensayos Clinicos - Pediatric Oncology DepartmentMadrid, 28009, Spain
Active, not recruiting
China Medical University HospitalTaichung, 404327, Taiwan
Completed
Saitama Cancer CenterKitaadachi-gun, 362-0806, Japan

Primary Outcome

  • Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity
    date_rangeTime Frame:
    through study completion, an average of 2.5 year

Secondary Outcome

  • Number of participants with dose modifications
    date_rangeTime Frame:
    through study completion, an average of 2.5 year

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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