En studie av fortsatt behandling med regorafenib hos deltakere med solide svulster som har deltatt i andre Bayer-studier
En enkeltarms, åpen, multisenter fase 2-studie av regorafenib hos deltakere som har blitt behandlet i en tidligere Bayer-sponset regorafenib-studie (monoterapi eller kombinasjonsbehandling) som har nådd det primære fullføringsendepunktet eller hoveddataanalysen eller har blitt stoppet For tidlig.
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Hauts-de-France
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Lille, Hauts-de-France, Frankrike, 59000
- CHU Lille - Hopital Claude Huriez - Service Gastro-entrologie adulte
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Île-de-France Region
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Clichy, Île-de-France Region, Frankrike, 92110
- Hôpital Beaujon - Clichy
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Villejuif, Île-de-France Region, Frankrike, 94800
- Hôpital Paul Brousse - Villejuif
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Saitama
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Kitaadachi, Saitama, Japan, 362-0806
- Saitama Cancer Center
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-
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Madrid, Spania, 28009
- Hospital Infantil Universitario Nino Jesus | Oncologia Pediatrica
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital | Oncology
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Taichung, Taiwan, 404327
- China Medical University Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Regorafenib
Adult and pediatric patients from completed Bayer-sponsored regorafenib trials who are benefiting from regorafenib treatment. |
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). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antall deltakere med alvorlige bivirkninger (SAE) og protokollspesifiserte AE og deres alvorlighetsgrad
Tidsramme: gjennom studiegjennomføring, gjennomsnittlig 2,5 år
|
gjennom studiegjennomføring, gjennomsnittlig 2,5 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antall deltakere med doseendringer
Tidsramme: gjennom studiegjennomføring, gjennomsnittlig 2,5 år
|
gjennom studiegjennomføring, gjennomsnittlig 2,5 år
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 22551
- 2023-507084-19-00 (Registeridentifikator: CTIS (EU))
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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