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Studienlocations (3 von 41)
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin 12200 Berlin (Berlin) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Jena 07747 Jena (Thüringen) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Koeln 50937 Koeln (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps
Universitaetsklinikum Leipzig 04103 Leipzig (Sachsen) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Tuebingen 72076 Tuebingen (Baden-Württemberg) GermanyAbgeschlossen» Google-MapsUniversitatsklinikum Ulm 89081 Ulm (Baden-Württemberg) GermanyRekrutierend» Google-MapsCity of Hope National Medical Center 91010 Duarte United StatesRekrutierend» Google-MapsNew York University Langone Health 10016 New York United StatesRekrutierend» Google-MapsUniversity of Texas MD Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-MapsFred Hutchinson Cancer Center 98109-1023 Seattle United StatesAbgeschlossen» Google-MapsUniversity of Washington 98109-1023 Seattle United StatesRekrutierend» Google-MapsRoyal Adelaide Hospital 5000 Adelaide AustraliaRekrutierend» Google-MapsMonash Medical Centre 3168 Clayton AustraliaRekrutierend» Google-MapsAustin Health, Austin Hospital 3084 Heidelberg AustraliaRekrutierend» Google-MapsThe Alfred Hospital 3004 Melbourne AustraliaRekrutierend» Google-MapsUniversitaetsklinikum Allgemeines Krankenhaus Wien 1090 Wien AustriaAbgeschlossen» Google-MapsTom Baker Cancer Centre T2N 2T9 Calgary CanadaRekrutierend» Google-MapsUniversity of Alberta T6G 2P4 Edmonton CanadaRekrutierend» Google-MapsVancouver General Hospital, Gordon and Leslie Diamond Health Care Centre V5Z 1M9 Vancouver CanadaRekrutierend» Google-MapsCentre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez 59000 Lille FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Nice 06202 Nice cedex 3 FranceRekrutierend» Google-MapsHopital Saint Antoine 75012 Paris FranceRekrutierend» Google-MapsInstitut Universitaire du Cancer Toulouse Oncopole 31059 Toulouse cedex 9 FranceRekrutierend» Google-MapsAzienda Socio Sanitaria Territoriale Papa Giovanni xxiii 24127 Bergamo ItalyRekrutierend» Google-MapsIRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola 40138 Bologna ItalyRekrutierend» Google-MapsAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia 25123 Brescia ItalyRekrutierend» Google-MapsIRCCS Ospedale San Raffaele 20132 Milano ItalyAbgebrochen» Google-MapsAzienda Ospedaliera Policlinico Umberto I 00161 Roma ItalyRekrutierend» Google-MapsAkita University Hospital 010-8543 Akita-shi JapanRekrutierend» Google-MapsNational Cancer Center Hospital East 277-8577 Kashiwa-shi JapanRekrutierend» Google-MapsFukushima Medical University Hospital 960-1295 Fukushima-shi JapanRekrutierend» Google-MapsYokohama City University Medical Center 232-0024 Yokohama-shi JapanRekrutierend» Google-MapsErasmus Medisch Centrum 3015 CN Rotterdam NetherlandsRekrutierend» Google-MapsHospital Universitario Virgen del Rocio 41013 Sevilla SpainRekrutierend» Google-MapsComplejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca 37007 Salamanca SpainRekrutierend» Google-MapsInstitut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol 08916 Badalona SpainRekrutierend» Google-MapsHospital Clinico Universitario de Valencia 46010 Valencia SpainRekrutierend» Google-MapsClinica Universidad de Navarra 31008 Pamplona SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsBagcilar Medipol Mega Universite Hastanesi 34214 Istanbul TurkeyRekrutierend» Google-MapsIzmir Ekonomi Universitesi Medical Point Hastanesi 35575 Izmir TurkeyRekrutierend» Google-Maps
1. Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs) (Time Frame - Up to 29 days)
2. Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs) (Time Frame - Up to approximately 28 weeks)
3. Dose Escalation Phase: Number of participants who experience one or more serious TEAEs (Time Frame - Up to approximately 28 weeks)
4. Dose Escalation Phase: Number of participants who experience one or more treatment-related treatment-emergent adverse events (Time Frame - Up to approximately 28 weeks)
5. Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs) (Time Frame - Up to approximately 28 weeks)
6. Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission (CR) (Time Frame - Up to 68 days)
7. Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission with partial hematological recovery (CRh) (Time Frame - Up to 68 days)
8. Phase 2 Ph-IIC: Maximum concentration (Cmax) of blinatumomab SC1 and SC2 (Time Frame - Up to approximately 4 weeks)
9. Phase 2 Ph-IIC: Average concentration (Cavg) of blinatumomab SC1 and SC2 (Time Frame - Up to approximately 4 weeks)
10. Phase 2 Ph-IIC: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2 (Time Frame - Up to approximately 4 weeks)
11. Phase 2 Ph-IIC: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2 (Time Frame - Up to approximately 4 weeks)
Secondary outcome:
1. Dose Escalation Phase: Minimum concentration over the dosing interval (Cmin) of blinatumomab (Time Frame - Up to approximately 28 weeks)
2. Dose Escalation Phase: Cmax of blinatumomab (Time Frame - Up to approximately 28 weeks)
3. Dose Escalation Phase: Tmax of blinatumomab (Time Frame - Up to approximately 28 weeks)
4. Dose Escalation Phase: AUC of blinatumomab (Time Frame - Up to approximately 28 weeks)
5. Dose Escalation Phase and Phase 2 (Ph-IIC cohort): Number of participants who achieve CR/CRh (Time Frame - Up to 68 days)
6. Dose Escalation, Dose Expansion, and Ph-IIC: Number of participants with incidence of anti-blinatumomab antibody formation (Time Frame - Up to approximately 28 weeks)
7. Dose Expansion Phase: Cmin of blinatumomab (Time Frame - Up to approximately 28 weeks)
8. Dose Expansion Phase: Cmax of blinatumomab (Time Frame - Up to approximately 28 weeks)
9. Dose Expansion Phase: Tmax of blinatumomab (Time Frame - Up to approximately 28 weeks)
10. Dose Expansion Phase: AUC of blinatumomab (Time Frame - Up to approximately 28 weeks)
11. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Relapse-Free Survival in participants who achieve CR/CRh within the first 2 cycles(R/R B-ALL) (Time Frame - Up to 68 days)
12. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Overall survival (OS) (Time Frame - Up to approximately 28 weeks)
13. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Duration of complete response (Time Frame - Up to approximately 28 weeks)
14. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more TEAEs (Time Frame - Up to approximately 28 weeks)
15. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more serious treatment-emergent adverse event (Time Frame - Up to approximately 28 weeks)
16. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more treatment-related treatment-emergent adverse events (Time Frame - Up to approximately 28 weeks)
17. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more AEs (Time Frame - Up to approximately 28 weeks)
18. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Summary scores of quality of life at each assessment as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) (Time Frame - Baseline (Day 1) up to approximately 28 weeks)
19. Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Change from baseline of quality of life as assessed by the EORTC QLQ-C30 (Time Frame - Baseline (Day 1) up to approximately 28 weeks)
Experimental: Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1) Cohorts of at least 3 participants each will be treated with escalating doses of bilinatumomab to determine the maximum tolerated dose (MTD). The MTD will be defined as the dose for which the estimate of the toxicity rate from an isotonic regression (Yan et al, 2017) is closest to the target toxicity rate. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy will be assessed.
Experimental: Dose Expansion Phase: Blinatumomab SC1 Up to 4 cohorts of participants with R/R B-ALL will be enrolled to the preliminary recommended phase 2 dose (RP2D) and schedule determined from dose escalation phase. Each cohort will aim to further assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy.
Experimental: Ph-IIC: Clinical PK Evaluation of SC Blinatumomab Formulations 1 cohort of participants will be enrolled into the Ph-IIC arm. The clinical PK evaluation cohort (Ph-IIC) will be conducted to compare the PK of SC1 and SC2 formulations at the RP2D determined from the dose expansion phase, in participants with R/R B-ALL.