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Studienlocations (3 von 35)
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für Kinder 13353 Berlin (Berlin) GermanyRekrutierend» Google-MapsHopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO) 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsUCSF Benioff Children's Hospital 94143 San Francisco United StatesRekrutierend» Google-Maps
Children's National Medical Center 20010 Washington United StatesRekrutierend» Google-Maps Ansprechpartner: braintumorresearch@childrensnational.org Phone: 202-476-5000» Ansprechpartner anzeigenLurie Children's Hospital of Chicago 60611 Chicago United StatesRekrutierend» Google-MapsJohns Hopkins Hospital 21231 Baltimore United StatesAbgebrochen» Google-MapsDana-Farber Cancer Institute 02215 Boston United StatesRekrutierend» Google-MapsCS Mott Children's Hospital 48109 Ann Arbor United StatesRekrutierend» Google-MapsSt. Louis Children's Hospital 63110 Saint Louis United StatesRekrutierend» Google-MapsNYU Langone Health 10016 New York United StatesRekrutierend» Google-MapsDuke Cancer Center 27710 Durham United StatesRekrutierend» Google-MapsDoernbecher Children's Hospital Oregon & Health Science University 97239 Portland United StatesAbgebrochen» Google-MapsChildren's Hospital of Philadelphia 19104 Philadelphia United StatesRekrutierend» Google-MapsTexas Children's Hospital 77030 Houston United StatesRekrutierend» Google-MapsUniversity of Utah 84113 Salt Lake City United StatesRekrutierend» Google-MapsSeattle Children's Hospital 98105 Seattle United StatesRekrutierend» Google-MapsQueensland Children's Hospital 4101 Brisbane AustraliaRekrutierend» Google-MapsRoyal Children's Hospital 3052 Parkville AustraliaRekrutierend» Google-MapsPerth Children's Hospital WA 6009 Perth AustraliaRekrutierend» Google-MapsSydney Children's Hospital NSW 2031 Randwick AustraliaRekrutierend» Google-MapsThe Children's Hospital at Westmead 2145 Westmead AustraliaRekrutierend» Google-MapsCentre Hospitalier Universitaire Ste-Justine H3T 1C5 Montreal CanadaRekrutierend» Google-MapsMontreal Children's Hospital H4A 3J1 Montreal CanadaRekrutierend» Google-MapsCentre Mère-Enfant Soleil du CHU G1V 4G2 Québec CanadaRekrutierend» Google-MapsRigshospitalet Copenhagen DenmarkRekrutierend» Google-MapsRambam Health Care Campus 3109601 Haifa IsraelRekrutierend» Google-MapsSchneider Children's Medical Center of Israel 4920235 Petah Tikva IsraelRekrutierend» Google-MapsThe Chaim Sheba Medical Center 5265601 Ramat Gan IsraelRekrutierend» Google-MapsSeoul National University Hospital 3080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital - Yonsei University 3722 Seoul Korea, Republic ofRekrutierend» Google-MapsPrincess Maxima Center for Pediatric Oncology 3584 CS Utrecht NetherlandsRekrutierend» Google-MapsKK Women's and Children's Hospital 229899 Singapore SingaporeRekrutierend» Google-MapsUniversitäts-Kinderspital Zürich - Eleonorenstiftung 8032 Zürich SwitzerlandRekrutierend» Google-MapsUCL Great Ormond Street Institute of Child Health WC1N 1EH London United KingdomRekrutierend» Google-MapsNewcastle University NE1 7RU Newcastle Upon Tyne United KingdomRekrutierend» Google-Maps
1. Arm 1: Overall response rate (ORR) by independent radiology review committee (IRC) based on RANO criteria (Time Frame - Up to 48 months): ORR defined as the proportion of patients with best overall confirmed response of complete response (CR) or partial response (PR) by RANO criteria
2. Arm 2: Assess the safety and tolerability of DAY101 (Time Frame - Up to 48 months): Type, frequency, and severity of treatment-emergent adverse events and laboratory
3. Arm 3: Overall response rate (ORR) by independent radiology review committee (IRC) based on RECIST v1.1 criteria (Time Frame - Up to 48 months): Measured by the proportion of patients with best overall confirmed response of CR or PR by RECIST v1.1 criteria
Secondary outcome:
1. Relationship between pharmacokinetics (PK) and drug effects (Time Frame - Up to 48 months): Pharmacokinetic profile of DAY101 (e.g., area under the concentration-time curve [AUC], Cmin, etc.)
2. Effect on electrocardiogram (ECG) and QT interval corrected for heart rate by Fridericia's formula (QTcF) prolongation (Time Frame - Up to 48 months): Change from baseline QT interval corrected for HR by Fridericia's formula (ΔQTcF); change from baseline PR interval (ΔPR); change from baseline QRS interval (ΔQRS); change from baseline heart rate (ΔHR); ECG waveform morphology
3. ORR by Investigator (Time Frame - Up to 48 months): Measured by the proportion of patients with best overall confirmed response of CR or PR by RANO (Arms 1 & 2) or RECIST (Arm 3) criteria
4. Evaluate the concordance of prior local laboratory BRAF molecular profiling with a central BRAF alteration assay being evaluated by the Sponsor (Time Frame - Up to 48 months): Molecular analysis of cells obtained from archival tissue
5. Arm 1: Evaluate visual acuity (VA) outcomes compared with baseline (Time Frame - Up to 48 months): Measured by Teller Acuity Cards® II
6. Arms 1 & 2: ORR by IRC and Investigator using RAPNO criteria (Time Frame - Up to 48 months): Measured by the proportion of patients with best overall confirmed response of CR or PR by RAPNO-LGG criteria
7. Arms 1 & 2: Progression free survival (PFS) using RANO and RAPNO criteria by 1) an IRC and 2) the treating Investigator (RANO only) (Time Frame - Up to 48 months): Measured by the time following initiation of DAY101 to progression or death in patients treated with DAY101
8. Arms 1 & 2: Duration of response (DOR) with best overall response of CR or PR using RANO and RAPNO criteria by 1) an IRC and 2) the treating Investigator (RANO only) (Time Frame - Up to 48 months): Measured by the length of response in patients with best overall confirmed response of CR or PR by RANO and RAPNO criteria
9. Arms 1 & 2: Time to response following initiation of DAY101 (Time Frame - Up to 48 months): Measured by the time to first response following initiation of DAY101 in patients with best overall confirmed response of CR or PR by RANO and RAPNO criteria by 1) an IRC and 2) the treating Investigator (RANO only)
10. Arms 1 & 2: Clinical benefit rate based on the proportion of patients with best overall response using RANO or RAPNO criteria (Time Frame - Up to 48 months): Measured on the proportion of patients with best overall response of CR, PR, or SD lasting 12 months or more following initiation of DAY101 by 1) an IRC and 2) the treating Investigator (RANO only)
11. Arms 1 & 3: Assess the safety and tolerability of DAY101 (Time Frame - Up to 48 months): Type, frequency, and severity of treatment-emergent adverse events and laboratory abnormalities
12. Arm 3: Duration of response (DOR) with best overall response of CR or PR using RECIST v1.1 criteria by 1) an IRC and 2) the treating Investigator (Time Frame - Up to 48 months): Measured by the length of response in patients with best overall confirmed response of CR or PR by RECIST v1.1 criteria
13. Arm 3: Time to response following initiation of DAY101 (Time Frame - Up to 48 months): Measured by the time to first response following initiation of DAY101 in patients with best overall confirmed response of CR or PR by RECIST v1.1 criteria by 1) an IRC and 2) the treating Investigator
14. Arm 3: Clinical benefit rate based on the proportion of patients with best overall response using RECIST v1.1 criteria (Time Frame - Up to 48 months): Measured on the proportion of patients with best overall response of CR, PR, or SD lasting 12 months or more following initiation of DAY101 by 1) an IRC and 2) the treating Investigator