Date d’enregistrement de l’étude
1 déc. 2020
Intégration du premier participant
4 févr. 2021
Statut de recrutement
Not Recruiting
Titre scientifique
(Source de données: WHO)
TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL
Type d’étude
(Source de données: WHO)
Interventional clinical trial of medicinal product
Conception de l’étude
(Source de données: 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: 13
Phase
(Source de données: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no
Points finaux primaires
(Source de données: 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/biomarkerpositive 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 8 years
Points finaux secondaires
(Source de données: 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, CNSCBR, and CNS-PFS per RANO
6. Cohorts A, B, C, D, I, J, and K: INV-assessed CNS-ORR, CNS-DOR, CNSCBR, and CNS-PFS per RANO
7. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, and N: IRC-assessed ORR, DOR, CBR, and PFS per INRC
8. Cohorts A, B, C, D, E, F, H, I, J, K, L, M, and N: INV-assessed ORR, DOR, CBR, and PFS per INRC
9. Cohorts A, B, C, D, I, J, and K: IRC-assessed IC-ORR, IC-DOR, IC-CBR, IC-PFS rate per RECIST v1.1
10. Cohorts A, B, C, D, I, J, and K: INV-assessed IC-ORR, IC-DOR, ICCBR, IC-PFS per RECIST v1.1
11. 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
12. Descriptive endpoint of time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30
and EORTC IL71
13. Incidence, type, and severity of adverse events (based on the NCI CTCAE v5.0), including serious adverse events
14. Concentration of study treatment at specified timepoints
15. Incidence of ADAs during the study relative to the prevalence of ADAs at baseline
16. Relationship between ADA status and efficacy, safety, or pharmacokinetic endpoints
17. Cohort A, B and K: for pediatric patients - evaluate the acceptability and palatability of pralsetinib and;Timepoint(s) of evaluation of this end point: 1-16. Approximately 8 years
17. Day 1 of Cycle 1
Contact pour informations
(Source de données: WHO)
F. Hoffman-La Roche Ltd.