En undersøgelse af INCB099280 i kombination med axitinib hos voksne med avancerede solide tumorer
8. maj 2026 opdateret af: Incyte Corporation
Et fase 1/2-studie af INCB099280 i kombination med axitinib hos voksne med avancerede solide tumorer
Denne undersøgelse udføres for at evaluere sikkerheden og tolerabiliteten af INCB099280 i kombination med axitinib og for at vurdere antitumoraktiviteten af INCB099280 i kombination med axitinib.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Cambridge, Det Forenede Kongerige, CB2 0QQ
- Addenbrookes Hospital
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Glasgow, Det Forenede Kongerige, G12 0YN
- Beatson West of Scotland Cancer Centrewester
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London, Det Forenede Kongerige, SE1 9RT
- Guys Hospital
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London, Det Forenede Kongerige, EC1A 7BE
- St Bartholomew's Hospital
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London, Det Forenede Kongerige, SW3 6JJ
- The Royal Marsden
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Sutton, Det Forenede Kongerige, SM2 5PT
- The Royal Marsden Nhs Foundation Trust - Sutton
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Histologisk bekræftede fremskredne solide tumorer (protokoldefinerede udvalgte solide tumorer) med målbare læsioner pr. responsevalueringskriterier i solide tumorer version 1.1 (RECIST v1.1), som anses for ikke-modtagelige for kirurgi eller andre helbredende behandlinger eller procedurer.
- Skal have sygdomsprogression på eller efter behandling med mindst én tidligere systemisk kemoterapi.
- Eastern Cooperative Oncology Group præstationsstatusscore på 0 eller 1.
- Forventet levetid > 12 uger.
- Vilje til at undgå graviditet.
Ekskluderingskriterier:
- Kendt yderligere malignitet, der skrider frem eller kræver aktiv behandling.
- Metastaser i centralnervesystemet (CNS), der kræver behandling og/eller leptomeningeal sygdom.
- Toksicitet fra tidligere behandling, der ikke er nået til protokoldefinerede grænser.
- Forudgående modtagelse af et anti-PD-1-, anti-PD-L1- eller anti-PD-L2-middel; behandling med en immunmodulator (f.eks. CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T-celle).
- Forudgående terapi med antiangiogene TKI'er med små molekyler rettet mod VEGF-vejen
- Deltagelse i et andet interventionelt klinisk studie under modtagelse af INCB099280.
- Nedsat hjertefunktion eller klinisk signifikant hjertesygdom.
- Anamnese eller tegn på interstitiel lungesygdom, herunder ikke-infektiøs pneumonitis.
- Tilstedeværelse af gastrointestinale tilstande, der kan påvirke lægemiddelabsorptionen.
- Enhver autoimmun sygdom, der kræver systemisk behandling inden for de seneste 5 år.
- Diagnose af primær immundefekt eller modtage kronisk systemisk steroidbehandling med en daglig dosis på over 10 mg prednison eller tilsvarende.
- Aktiv infektion, der kræver systemisk terapi.
- Historie om organtransplantation, herunder stamcelletransplantation.
- Modtagelse af systemiske antibiotika inden for 28 dage efter første dosis af undersøgelsesbehandling.
- Brug af probiotika er forbudt under screening og i hele undersøgelsesbehandlingsperioden.
- Modtog en levende vaccine inden for 28 dage efter den planlagte start af studielægemidlet.
- Laboratorieværdier uden for de protokoldefinerede områder.
- Utilstrækkelig organfunktion.
Andre protokol-definerede inklusions-/eksklusionskriterier kan være gældende.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Del 1: Dosiseskalering
Op til 6 doser INCB099280 administreret to gange dagligt (BID) i kombination med axitinib BID vil blive evalueret for at identificere dosis(er) til yderligere evaluering i studiets dosisudvidelsesfase.
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Indgives som specificeret i behandlingsarmbeskrivelsen
Indgives som specificeret i behandlingsarmbeskrivelsen
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Eksperimentel: Del 2: Dosisudvidelse
Efter afslutningen af del 1 vil deltagerne blive tilmeldt 1 af 2 sygdomsspecifikke kohorter: Kohorte 1: Voksne med clear-celle gynækologisk cancer med mindst 50 % clear-cell histologi, hvis sygdom udviklede sig på eller efter mindst 1 tidligere linje af systemisk kemoterapi og er ikke kandidater til helbredende kirurgi eller (kemo)stråling.
Kohorte 2: Voksne med sjældne histologiske subtype epitelkræft i den gynækologiske kanal, hvis sygdom udviklede sig på eller efter mindst 1 tidligere linje af systemisk kemoterapi og ikke er kandidater til helbredende kirurgi eller (kemo)stråling.
En eller to doser kan vælges fra del 1 for hver kohorte i del 2-udvidelsen.
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Indgives som specificeret i behandlingsarmbeskrivelsen
Indgives som specificeret i behandlingsarmbeskrivelsen
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Tidsramme: up to 3 weeks
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Any adverse event that ws at least possibly related to study treatment and met protocol-specified criteria was classified as a DLT.
For the purpose of dose finding, decisions on dose were based on DLTs observed during the first 21 days of treatment.
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up to 3 weeks
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Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Tidsramme: up to approximately 1 year
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An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related.
An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.
A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
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up to approximately 1 year
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Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
Tidsramme: up to approximately 1 year
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An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related.
An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.
A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
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up to approximately 1 year
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Part 2: Objective Response
Tidsramme: up to 2 years
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Objective response was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1).
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm).
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
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up to 2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Part 2: Number of Participants With Any TEAE
Tidsramme: up to 2 years
|
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related.
An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.
A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
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up to 2 years
|
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Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
Tidsramme: up to 2 years
|
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related.
An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.
A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
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up to 2 years
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Part 1: Objective Response
Tidsramme: up to 335 days
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Objective response was defined as the percentage of participants with a BOR of CR or PR by investigator assessment per RECIST v1.1.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm).
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
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up to 335 days
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Part 1: Disease Control
Tidsramme: up to 335 days
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Disease control was defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD) by investigator assessment per RECIST v1.1.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm.
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
PD: progression of a target or non-target lesion or presence of a new lesion.
SD: no change in target lesions to qualify for CR, PR, or PD.
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up to 335 days
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Part 1: Duration of Response (DOR)
Tidsramme: up to 335 days
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DOR was defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurred earlier.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm.
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
PD: progression of a target or non-target lesion or presence of a new lesion.
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up to 335 days
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Part 1: INCB099280 and Axitinib Plasma Concentrations
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Blood samples were collected for the analysis of INCB099280 and axitinib concentrations.
Per Protocol, PK samples for axitinib were only to be analyzed in case of a concern that axitinib was not as active as expected.
Due to the early termination of the study before readout, these samples were not analyzed.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: Cmax of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Cmax was defined as the maximum observed concentration of INCB099280.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: Tmax of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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tmax was defined as the time to the maximum concentration of INCB099280.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: AUC0-4h of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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AUC0-4h was defined as area under the steady-state plasma or serum concentration-time curve from 0 to 4 hours.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: Cmax,ss of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Cmax,ss was defined as the maximum observed concentration at steady state.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: Tmax,ss of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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tmax,ss was defined as the time to the maximum concentration of INCB099280 at steady state.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: AUC0-12h of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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AUC0-12h was defined as the area under the steady-state plasma or serum concentration-time curve from 0 to 12 hours.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: Cavg of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Cavg was defined as the average concentration of INCB099280.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: Ctau of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Ctau was defined as the concentration of INCB099280 at the end of a dose interval.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: t1/2 of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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t1/2 was defined as the apparent terminal-phase disposition half life of INCB099280.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: CLss/F of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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CLss/F was defined as the apparent oral dose clearance of INCB099280 at steady state.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Part 1: Vz/F of INCB099280 When Administered With Axitinib
Tidsramme: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Vz/F was defined as the apparent oral dose volume of distribution of INCB099280.
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Philomena Colucci, Incyte Corporation
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. april 2024
Primær færdiggørelse (Faktiske)
6. juni 2025
Studieafslutning (Faktiske)
6. juni 2025
Datoer for studieregistrering
Først indsendt
10. juli 2023
Først indsendt, der opfyldte QC-kriterier
10. juli 2023
Først opslået (Faktiske)
18. juli 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- tyrosinkinasehæmmer
- kombinationsterapi
- livmoderhalskræft
- æggelederkræft
- livmoderhalskræft
- livmoderkræft
- carcinosarkom
- kræft i skeden
- vulva cancer
- kræft i gynækologiske kanaler
- primær bughindekræft
- klar cellehistologi
- mucinøst adenokarcinom
- serøst adenokarcinom
- neuroendokrin histologi
- småcellet histologi
- lille molekyle pdl1-hæmmer
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i det endokrine system
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Neoplasmer efter histologisk type
- Livmodersygdomme
- Kønssygdomme, kvindelige
- Neoplasmer i endokrine kirtler
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Ovariesygdomme
- Adnexale sygdomme
- Genitale neoplasmer, kvindelige
- Gonadale lidelser
- Karcinom
- Livmoderhalssygdomme
- Sarkom
- Neoplasmer, bindevæv og blødt væv
- Cystadenocarcinom
- Neoplasmer, cystiske, mucinøse og serøse
- Neoplasmer, komplekse og blandede
- Vulva sygdomme
- Æggeledersygdomme
- Vaginale sygdomme
- Ovariale neoplasmer
- Uterine cervikale neoplasmer
- Cystadenocarcinom, serøs
- Carcinosarkom
- Vulva neoplasmer
- Adenocarcinom, slimet
- Æggelederneoplasmer
- Uterine neoplasmer
- Vaginale neoplasmer
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Azoler
- Kulbrinter
- Kulbrinter, cyklisk
- Carboxylsyrer
- Kulbrinter, aromatisk
- Amider
- Benzenderivater
- Syrer, carbocykliske
- Benzoates
- Benzamider
- Indazoles
- Pyrazoler
- Axitinib
Andre undersøgelses-id-numre
- INCB99280-201
- 2022-003663-13 (EudraCT nummer: CTIS (EU))
- 2023-510281-27-00 (Registry Identifier: EU CT Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Incyte deler data med kvalificerede eksterne forskere, efter at et forskningsforslag er indsendt.
Disse anmodninger gennemgås og godkendes af et bedømmelsespanel på grundlag af videnskabelig fortjeneste.
Alle opgivne data er anonymiseret for at respektere privatlivets fred for patienter, der har deltaget i forsøget i overensstemmelse med gældende love og regler.
Tilgængeligheden af forsøgsdata er i overensstemmelse med kriterierne og processen beskrevet på https://www.incyte.com/our-company/compliance-and-transparency
IPD-delingstidsramme
Data vil blive delt efter den primære offentliggørelse eller 2 år efter undersøgelsen er afsluttet for markedsgodkendte produkter og indikationer.
IPD-delingsadgangskriterier
Data fra kvalificerede undersøgelser vil blive delt med kvalificerede forskere i henhold til kriterierne og processen beskrevet i afsnittet om datadeling på www.incyteclinicaltrials.com
internet side.
For godkendte anmodninger vil forskerne få adgang til anonymiserede data i henhold til en datadelingsaftale.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Avancerede solide tumorer
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Novartis PharmaceuticalsAfsluttetcMET Dysegulation Advanced Solid TumorsØstrig, Danmark, Sverige, Det Forenede Kongerige, Spanien, Tyskland, Holland, Forenede Stater
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Shanghai Qilu Pharmaceutical Research and Development...Ikke rekrutterer endnuMSI-H eller dMMR Advanced Solid Tumors
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRekrutteringKRAS G12C Mutant Advanced Solid TumorsKina
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D3 Bio (Wuxi) Co., LtdRekrutteringHER-2 Positive Advanced Solid TumorsAustralien, Forenede Stater, Kina
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AmgenAktiv, ikke rekrutterendeKRAS p.G12C Mutant Advanced Solid TumorsForenede Stater, Frankrig, Canada, Spanien, Belgien, Østrig, Australien, Ungarn, Grækenland, Japan, Brasilien, Tyskland, Schweiz, Portugal, Rumænien, Sydkorea
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Shanghai Pudong HospitalUTC Therapeutics Inc.Trukket tilbageMesothelin-positive Advanced Refractory Solid TumorsKina
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Krankenhaus NordwestAfsluttetHer2/Neu Positive Advanced Solid TumorsTyskland
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Memorial Sloan Kettering Cancer CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
Kliniske forsøg med INCB099280
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Incyte CorporationAktiv, ikke rekrutterendeAvanceret solid tumorBrasilien, Grækenland, Kina, Rumænien, Georgien, Sydafrika, Ungarn, New Zealand, Tyrkiet (Türkiye)
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Incyte CorporationAktiv, ikke rekrutterendeKutant planocellulært karcinomSpanien, Frankrig, Brasilien, Ungarn, Chile, Rumænien, Sydafrika, Australien, Canada, Kroatien, Montenegro, New Zealand, Nordmakedonien, Sydkorea, Tyrkiet (Türkiye)
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Incyte CorporationAfsluttetLivmoderhalskræft | Nasopharyngealt karcinom | Mesotheliom | Avanceret solid tumor | Småcellet lungekræft | Esophageal pladecellekarcinom | Urothelialt karcinom | Merkel cellekarcinom | Hepatocellulært karcinom | Kutant planocellulært karcinom | MSI-H/dMMR-tumorer | PD-L1 amplificeret tumor (9p24.1)Frankrig, Forenede Stater, Japan, Belgien, Australien
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Incyte CorporationAfsluttetSunde deltagereDet Forenede Kongerige
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Abramson Cancer Center at Penn MedicineIncyte CorporationTrukket tilbageHepatocellulært karcinomForenede Stater
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Incyte CorporationMirati Therapeutics Inc.AfsluttetAvancerede solide tumorerForenede Stater, Spanien, Det Forenede Kongerige, Italien