Clinical trial • Phase II • Oncology

REGORAFENIB for Solid malignant tumors

Phase II trial of REGORAFENIB for Solid malignant tumors. open-label, none/not specified-controlled. 6 participants.

Overview

open-label, none/not specified-controlled Phase II trial across 5 sites in Spain, France.

Recruits 6 paediatric patients.

Pregnancy Exclusion: Participants with a beta-human chorionic gonadotropin (hCG) test result consistent with pregnancy.
Vulnerable Population: Vulnerable population selected: pediatric participants are included (protocol/period details mention "Adult and pediatric patients"; one site is a pediatric hospital). Subject information and informed consent forms are provided (documents listed: L1_ICF_FR_FR_Master PIIC_public; L1_ICF_FR_FR_Consent Form for Expecting Parents Male Study Participant_public; L1_ICF_FR_FR_Consent Form for Expecting Parents Female Study Participant_public; L1_SIS_and_ICF_Study_Update_Public_FR_FR). Assent procedures are not explicitly detailed in the available records.

{"criterion_text":"- Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving regorafenib as study treatment."}
{"criterion_text":"- 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."}
{"criterion_text":"- 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."}

{"criterion_text":"- Ineligibility, for medical reasons, to start the subsequent cycle in the respective feeder study."}
{"criterion_text":"- Participants with a beta-human chorionic gonadotropin (hCG) test result consistent with pregnancy."}
{"criterion_text":"- Participants are using one or more of the prohibited medications listed in the respective feeder study protocol."}
{"criterion_text":"- Participant has been previously permanently discontinued from regorafenib treatment."}

{"endpoint_text":"- Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity","definition_or_measurement_approach":""}

{"endpoint_text":"- Number of participants with dose modifications","definition_or_measurement_approach":""}

Planned Sample Size: 6
Recruitment Window Months: 49
Consent Approach: Informed consent obtained using subject information and informed consent forms (documents available: L1_ICF_FR_FR_Master PIIC_public; L1_ICF_FR_FR_Consent Form for Expecting Parents Male Study Participant_public; L1_ICF_FR_FR_Consent Form for Expecting Parents Female Study Participant_public; L1_SIS_and_ICF_Study_Update_Public_FR_FR). Consent forms available in French (FR). For pediatric participants parental/expecting-parents consent forms are provided; explicit details on assent and age-specific consent procedures are not specified in the available records.

Name: Fisher Clinical Services GmbH
Responsibilities: Sponsor duties (code 14) and clinical supply/clinical services (contact: csosbayerteam@thermofisher.com) as listed in trial record

{"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Sponsor duties (code 14) as listed in trial record","organisation_type":"Pharmaceutical company"}

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