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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Malignant Tumors
• Intervention / Treatment: Drug: Regorafenib (Stivarga, BAY73-4506)

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• France
  • Bordeaux, France, 33076
    • Withdrawn
    • Institut Bergonié - Unicancer Nouvelle Aquitaine
  • Clichy, France, 92110
    • Recruiting
    • Hôpital Beaujon - Clichy
  • Lille, France, 59037
    • Recruiting
    • Hôpital Claude Huriez - Lille
  • Villejuif, France, 94800
    • Recruiting
    • Hôpital Paul Brousse - Villejuif
• India
  • West Bengal
    • Kolkata, West Bengal, India, 700017
      • Withdrawn
      • Belle Vue Clinic
• Japan
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 362-0806
      • Recruiting
      • Saitama Cancer Center
• Korea, Republic of
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 3080
      • Recruiting
      • Seoul National University Hospital
• Spain
  • Madrid, Spain, 28009
    • Recruiting
    • Hospital Infantil Universitario Nino Jesus | Unidad de Ensayos Clinicos - Pediatric Oncology Department
• Taiwan
  • Taichung, Taiwan, 404327
    • Active, not recruiting
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Measure	Time Frame
Number of participants with dose modifications	through study completion, an average of 2.5 year

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): April 27, 2026
• Study Completion (Estimated): April 27, 2026

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 22551; 2023-507084-19-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No