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

Last updated: June 22, 2025
Sponsor: Bayer
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neoplasms

Treatment

Regorafenib (Stivarga, BAY73-4506)

Clinical Study ID

NCT06246643
22551
2023-507084-19-00
  • Ages > 10
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is currently participating in any Bayer-sponsored regorafenib study andis receiving regorafenib as study treatment.

  • Participant is currently benefiting from treatment with regorafenib monotherapy. Allparticipants must meet criteria to initiate a subsequent cycle of therapy, asdetermined by the guidelines of the feeder protocol.

  • Any ongoing adverse events that require temporary treatment interruption must beresolved to baseline grade or assessed as stable and not requiring further treatmentinterruption by the investigator.

Exclusion

Exclusion Criteria:

  • Ineligibility, for medical reasons, to start the subsequent cycle in the respectivefeeder study.

  • Participants with a beta-human chorionic gonadotropin (hCG) test result consistentwith pregnancy.

  • Participants are using one or more of the prohibited medications listed in therespective feeder study protocol.

  • Participant has been previously permanently discontinued from regorafenib treatment.

Study Design

Total Participants: 13
Treatment Group(s): 1
Primary Treatment: Regorafenib (Stivarga, BAY73-4506)
Phase: 2
Study Start date:
January 24, 2024
Estimated Completion Date:
April 27, 2026

Connect with a study center

  • Institut Bergonié - Unicancer Nouvelle Aquitaine

    Bordeaux, 33076
    France

    Site Not Available

  • Hôpital Beaujon - Clichy

    Clichy, 92110
    France

    Site Not Available

  • Hopital Claude Huriez - Lille

    Lille, 59037
    France

    Site Not Available

  • Hôpital Claude Huriez - Lille

    Lille, 59037
    France

    Site Not Available

  • Hôpital Paul Brousse - Villejuif

    Villejuif, 94800
    France

    Site Not Available

  • Belle Vue Clinic

    Kolkata, West Bengal 700017
    India

    Site Not Available

  • Saitama Cancer Center

    Kitaadachi-gun, Saitama 362-0806
    Japan

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 3080
    Korea, Republic of

    Site Not Available

  • Hospital Infantil Universitario Nino Jesus - Oncologia Pediatrica

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Infantil Universitario Nino Jesus | Unidad de Ensayos Clinicos - Pediatric Oncology Department

    Madrid, 28009
    Spain

    Site Not Available

  • China Medical University Hospital

    Taichung, 404327
    Taiwan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.