Efficacy of Tuvusertib in Recurrent IDH mutant Astrocytoma with ATRX mutation, a phase II prospective trial.

Conditions

IDH1/2-mutated, ATRX-mutated and p53-mutated astrocytoma

Brief summary

The primary endpoint will be the 6-months PFS rate, defined as the proportion of patients alive and free of progression according to RANO 2.0 estimated by Kaplan-Meier at 6 months after the first dose of tuvusertib.

Detailed description

Objective response (ORR) locally assessed by PI according to RANO 2.0., Progression-free survival (PFS) locally assessed by PI according to RANO 2.0., Overall survival (OS)., TTNI Time to Next Intervention., Neurocognitive function using HVLT, TMT-A, TMT.B and COWA, and tests., Neurologic status: NANO scale and MMSE test., Functional status: Barthel index and Karnofsky index., Patients reported outcomes through the NCI-PRO-CTCAE Custom Survey and PGIC Questionnaires, Adverse events (AE)., Treatment-related AEs (TRAEs)., Treatment compliance, number of dose reductions / interruptions.

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Interventions

DRUGM1774

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the 6-months PFS rate, defined as the proportion of patients alive and free of progression according to RANO 2.0 estimated by Kaplan-Meier at 6 months after the first dose of tuvusertib.	—

Secondary

Measure	Time frame
Objective response (ORR) locally assessed by PI according to RANO 2.0., Progression-free survival (PFS) locally assessed by PI according to RANO 2.0., Overall survival (OS)., TTNI Time to Next Intervention., Neurocognitive function using HVLT, TMT-A, TMT.B and COWA, and tests., Neurologic status: NANO scale and MMSE test., Functional status: Barthel index and Karnofsky index., Patients reported outcomes through the NCI-PRO-CTCAE Custom Survey and PGIC Questionnaires, Adverse events (AE)., Treatment-related AEs (TRAEs)., Treatment compliance, number of dose reductions / interruptions.	—

Measure

Time frame

Objective response (ORR) locally assessed by PI according to RANO 2.0., Progression-free survival (PFS) locally assessed by PI according to RANO 2.0., Overall survival (OS)., TTNI Time to Next Intervention., Neurocognitive function using HVLT, TMT-A, TMT.B and COWA, and tests., Neurologic status: NANO scale and MMSE test., Functional status: Barthel index and Karnofsky index., Patients reported outcomes through the NCI-PRO-CTCAE Custom Survey and PGIC Questionnaires, Adverse events (AE)., Treatment-related AEs (TRAEs)., Treatment compliance, number of dose reductions / interruptions.

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Countries

Spain

Outcome results

None listed