beta
Trial Radar AI
Clinical Trial NCT06246643 for Solid Malignant Tumors is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies Phase 2 13

Active, not recruiting
Clinical Trial NCT06246643 is designed to study Treatment for Solid Malignant Tumors. It is a Phase 2 interventional study that is active, not recruiting, having started on 24 January 2024, with plans to enroll 13 participants. Led by Bayer, it is expected to complete by 27 April 2028. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
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. T...

Show More
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.

Conditions
Solid Malignant Tumors
Other Study IDs
  • 22551
  • 2023-507084-19-00 (Registry Identifier) (CTIS (EU))
NCT ID Number
NCT06246643
Start Date (Actual)
2024-01-24
Last Update Posted
2026-03-19
Completion Date (Estimated)
2028-04-27
Enrollment (Estimated)
13
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalRegorafenib
Adult and pediatric patients from completed Bayer-sponsored regorafenib trials who are benefiting from regorafenib treatment.
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).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of participants with dose modifications
through study completion, an average of 2.5 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
10 Years
Eligible Sexes
All
  • 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.
Bayer logoBayer187 active studies to explore
No contact data.
7 Study Locations in 5 Countries

Hauts-de-France

Hopital Claude Huriez - Lille, Lille, Hauts-de-France, 59037, France

Île-de-France Region

Hôpital Beaujon - Clichy, Clichy, Île-de-France Region, 92110, France
Hôpital Paul Brousse - Villejuif, Villejuif, Île-de-France Region, 94800, France

Saitama

Saitama Cancer Center, Kitaadachi-gun, Saitama, 362-0806, Japan

Seoul Teugbyeolsi

Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, 3080, South Korea
Hospital Infantil Universitario Nino Jesus | Oncologia Pediatrica, Madrid, 28009, Spain
China Medical University Hospital, Taichung, 404327, Taiwan