Clinical trial NCT06246643: A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Solid Malignant Tumors
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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 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.

Primary outcomes:
measure: Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity
timeFrame: through study completion, an average of 2.5 year
Secondary outcomes:
measure: Number of participants with dose modifications
timeFrame: through study completion, an average of 2.5 year
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon - Clichy
city: Lille
country: France
facility: Hopital Claude Huriez - Lille
city: Villejuif
country: France
facility: Hôpital Paul Brousse - Villejuif
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus | Unidad de Ensayos Clinicos - Pediatric Oncology Department
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: