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Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

ConditionsGrade 2 IDH1-mutant GliomaGrade 3 IDH1-mutant GliomaGliomaIDH1-mutant GliomaOligodendrogliomaOligodendroglioma IDH-1 Mutant and 1/p19q-codeletedAstrocytoma IDH Mutant Grade 3Astrocytoma IDH Mutant Grade 2
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuvation Bio Inc.

About this trial

This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \[BICR\] per modified Response Assessment in Neuro-Oncology \[RANO\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria

IDH1 mutation (e.g., R132H/C/G/S/L) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS).

Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection).

Measurable disease per modified RANO 2.0 confirmed by BICR during Screening.

Disqualifiers

Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma.

Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression

Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma.

Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.

Trial design

Design model

Single group

Treatments tested in this trial

  • Safusidenib

    Drug

    Safusidenib administered twice daily as a single agent orally on Days 1 to 28 of a 28-day cycle. Participants may continue treatment until disease progression or another reason for discontinuation occurs.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: SafusidenibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)

ORR defined as the proportion of participants with the confirmed best overall response of Complete Response (CR), Partial Response (PR) or Minor Response (MR) per modified RANO 2.0, assessed by BICR

Time frame
From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

Secondary outcomes

1

ORR per modified RANO 2.0 assessed by Investigator

ORR defined as the proportion of participants with the confirmed best overall response of CR, PR or MR per modified RANO 2.0, assessed by the Investigator

Time frame
From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
2

Volumetric Tumor Growth Rate (TGR) by BICR

TGR defined as the percentage change in tumor volume by unit of time, assessed by BICR

Time frame
From historical scans through the final scan in the study, approximately 18 months
3

Duration of Response (DOR) per modified RANO 2.0 assessed by BICR and by Investigator

DOR, time from the first documentation of objective response (CR, PR, or MR) to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR and by the Investigator or death from any cause, whichever occurs earlier.

Time frame
From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
4

Time to Next Intervention (TTNI)

TTNI, defined as the time from the first dose of study drug to the initiation of first subsequent anticancer therapy or death from any cause, whichever occurs earlier

Time frame
From the date of first dose of study drug until the date of the start of another anticancer treatment or date of death, approximately 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nuvation Bio Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: