Datum der Studienregistrierung
23.11.2020
Einschluss der ersten teilnehmenden Person
08.04.2021
Rekrutierungsstatus
Not Recruiting
Wissenschaftlicher Titel
(Datenquelle: WHO)
TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL
Studientyp
(Datenquelle: WHO)
Interventional clinical trial of medicinal product
Design der Studie
(Datenquelle: WHO)
Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: multi-cohort If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 10
Phase
(Datenquelle: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no
Primäre Endpunkte
(Datenquelle: WHO)
Main Objective: ? To evaluate the efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors (for tumor types that are assessed by RECIST v1.1) based on IRC-assessed ORR;Secondary Objective: ? To evaluate efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors, alteration/biomarker-positive primary CNS tumors at baseline and alteration/biomarker-positive advanced or metastatic neuroblastoma
? To evaluate the efficacy of study treatment in subgroup of patients with advanced or metastatic solid tumors that are alteration/biomarker-positive by blood-based NGS assay and alteration/biomarker-positive solid tumors with CNS metastases at baseline
? To evaluate the impact of study treatment on PROs of function and symptoms in patients with alteration/biomarker-positive advanced or metastatic solid tumors
? To evaluate the safety and tolerability of study treatment in patients with alteration/biomarker-positive solid tumors
? To characterize the pharmacokinetics of study treatment (and metabolite[s] if applicable)
? To evaluate the immune response to study treatment and potential effects of ADAs
;Primary end point(s): 1. IRC-assessed ORR based on confirmed (>= 4 weeks after initial documentation of response) objective response (per RECIST v1.1);Timepoint(s) of evaluation of this end point: Approximately 12 years
Sekundäre Endpunkte
(Datenquelle: WHO)
Secondary end point(s): 1. IRC-assessed DOR, CBR, and PFS per RECIST v1.1
2. INV-assessed ORR, DOR, CBR, and PFS per RECIST v1.1
3. IRC- and INV-assessed time to CNS progression per RECIST v1.1
4. OS
5. Cohorts A, B, C, D, I, J, and K: IRC-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO
6. Cohorts A, B, C, D, I, J, and K: INV-assessed CNS-ORR, CNS-DOR, CNS-CBR, and CNS-PFS per RANO
7. Cohorts A, B, D, E, F, G, H, I, J, and K: IRC-assessed ORR, DOR, CBR, and PFS per INRC
8. Cohorts A, B, D, E, F, G, H, I, J, and K: INV-assessed ORR, DOR, CBR, and PFS per INRC
9. IRC-assessed ORR, DOR, CBR, and PFS per RECIST v1.1 in patients with alteration/biomarker-positive ctDNA by blood-based NGS assay
10. INV-assessed ORR, DOR, CBR, and PFS per RECIST v1.1 in patients with alteration/biomarker-positive ctDNA by blood-based NGS assay
11. Cohorts A, B, C, D, I, J, and K: IRC-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS rate per RECIST v1.1
12. Cohorts A, B, C, D, I, J, and K: INV-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS per RECIST v1.1
13. Descriptive endpoint of time to confirmed deterioration, change from baseline, proportion of patients with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the EORTC QLQ-C30
14. Descriptive endpoint of time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC IL71
15. Incidence, type, and severity of adverse events (based on the NCI CTCAE v5.0), including serious adverse events
16. Concentration of study treatment at specified timepoints
17. Incidence of ADAs during the study relative to the prevalence of ADAs at baseline
18. Relationship between ADA status and efficacy, safety, or pharmacokinetic endpoints
19. Cohort K: for pediatric patients - evaluate the acceptability and palatability of pralsetinib with Acceptability Survey scores on Day 1 of Cycle 1
;Timepoint(s) of evaluation of this end point: 1-18. Approximately 12 years
19. Day 1 of Cycle 1
Kontakt für Auskünfte
(Datenquelle: WHO)
F. Hoffman-La Roche Ltd.