Recurrent Glioblastoma
Conditions
Brief summary
First cycle Dose Limiting Toxicities (DLTs) (Phase I), Objective Response Rate (ORR), calculated as the proportion of evaluable patients who have achieved, as best overall response (BOR), confirmed complete response (CR) or partial response (PR) through central retrospective assessment of RANO criteria (Phase II)
Detailed description
Overall safety profile of the combination of NMS-03305293 and TMZ characterized by type, frequency, severity (graded using the NCI CTCAE Version 5.0), duration of adverse events (AEs), ECGs and laboratory abnormalities, and relationship of AEs to the study treatment, Plasma pharmacokinetic profile of NMS-03305293 and possible identified metabolites (if appropriate) after oral administration, Renal clearance and fraction of NMS-03305293 and possible identified metabolites (if appropriate) excreted in urine, Secondary efficacy endpoints Phase I: -Objective Tumor Response (Partial and Complete Response) (RANO criteria) - Duration of response (DoR) - Progression-free survival (PFS) - Overall survival (OS), Secondary efficacy endpoints Phase II: - Duration of response (DoR) through central retrospective assessment of RANO criteria - Progression-free survival (PFS) and 6-month PFS rate - 9 and 12-month overall survival rates - Overall survival (OS)
Interventions
Sponsors
Nerviano Medical Sciences S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First cycle Dose Limiting Toxicities (DLTs) (Phase I), Objective Response Rate (ORR), calculated as the proportion of evaluable patients who have achieved, as best overall response (BOR), confirmed complete response (CR) or partial response (PR) through central retrospective assessment of RANO criteria (Phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall safety profile of the combination of NMS-03305293 and TMZ characterized by type, frequency, severity (graded using the NCI CTCAE Version 5.0), duration of adverse events (AEs), ECGs and laboratory abnormalities, and relationship of AEs to the study treatment, Plasma pharmacokinetic profile of NMS-03305293 and possible identified metabolites (if appropriate) after oral administration, Renal clearance and fraction of NMS-03305293 and possible identified metabolites (if appropriate) excreted in urine, Secondary efficacy endpoints Phase I: -Objective Tumor Response (Partial and Complete Response) (RANO criteria) - Duration of response (DoR) - Progression-free survival (PFS) - Overall survival (OS), Secondary efficacy endpoints Phase II: - Duration of response (DoR) through central retrospective assessment of RANO criteria - Progression-free survival (PFS) and 6-month PFS rate - 9 and 12-month overall survival rates - Overall survival (OS) | — |
Countries
Italy, Netherlands
Outcome results
None listed