Overview
Sponsor-declared trial summary
Solid malignant tumors
The primary purpose of the program is to enable participants, currently receiving regorafenib in a Bayer sponsored clinical trial and assessed by the principal investigator to be benefiting, to continue regorafenib treatment after their respective study has met its primary completion date, or main data analysis, or has…
Key facts
- Sponsor
- Bayer AG
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bayer AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
The primary purpose of the program is to enable participants, currently receiving regorafenib in a Bayer sponsored clinical trial and assessed by the principal investigator to be benefiting, to continue regorafenib treatment after their respective study has met its primary completion date, or main data analysis, or has been stopped prematurely and the documentation of safety
Secondary objectives 1
- Documentation of tolerability
Conditions and MedDRA coding
Solid malignant tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Study This is an open-label study that will enable participants currently receiving regorafenib in a Bayer-sponsored clinical trial to continue treatment after their respective study has been completed. A completed study is defined as one that has reached the primary completion endpoint, or main data analysis, or has been stopped prematurely, and the respective data have been cleaned.
|
Not Applicable | None | Regorafenib: Adult and pediatric patients from completed Bayer-sponsored regorafenib trials who are benefiting from regorafenib treatment. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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 4
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity
Secondary endpoints 1
- Number of participants with dose modifications
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10079495 · Product
- Active substance
- Regorafenib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 93.24 g gram(s)
- Max treatment duration
- 26 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER AG
- Paediatric formulation
- No
- Orphan designation
- No
PRD124397 · Product
- Active substance
- Regorafenib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 62.16 g gram(s)
- Max treatment duration
- 26 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER HEALTHCARE AG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- Kaiser-Wilhelm-Allee 1, Wiesdorf Wiesdorf
- City
- Leverkusen
- Postcode
- 51373
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Fisher Clinical Services GmbH ORG-100012942
|
Allschwil, Switzerland | Code 14 |
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 4 | 4 |
| Spain | Ended | 1 | 1 |
| Rest of world
Korea, Republic of, Japan, India, Taiwan
|
— | 6 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-03-07 | 2024-03-12 | 2024-04-23 | ||
| Spain | 2024-03-08 | 2024-09-23 | 2024-03-13 | 2024-03-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_EN_2023-507084-19-00_public | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR_Recruitment info ICF Procedure_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_FR_FR_Consent Form for Expecting Parents Female Study Participant_public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_FR_FR_Consent Form for Expecting Parents Male Study Participant_public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_FR_FR_Master PIIC_public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_FR_FR | 1.1 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_EN_2023-507084-19-00_public | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_ES_ES_2023-507084-19-00_public | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_FR_2023-507084-19-00_public | 1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-13 | France | Acceptable 2024-02-19
|
2024-02-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-21 | France | Acceptable 2024-03-15
|
2024-03-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-21 | Acceptable 2024-02-19
|
2024-02-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-03 | France | Acceptable 2025-01-17
|
2025-01-17 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-02 | France | Acceptable | 2025-11-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-27 | France | Acceptable 2025-12-23
|
2026-01-07 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-25 | France | Acceptable 2025-12-23
|
2026-02-25 |