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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safusidenib | Experimental | Safusidenib 250 mg BID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials at Nuvation Bio | Contact | 332-208-6102 | ClinicalTrials@nuvationbio.com |
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| Volumetric Tumor Growth Rate (TGR) by BICR |
TGR defined as the percentage change in tumor volume by unit of time, assessed by BICR |
| From historical scans through the final scan in the study, approximately 18 months |
| 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. | From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months |
| 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 | 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 |
| Progression Free Survival (PFS) per modified RANO 2.0 assessed by BICR and by Investigator | PFS, defined as the time from the first dose of study drug 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. | From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months |
| Time to Response (TTR) per modified RANO 2.0 assessed by BICR and by Investigator | TTR, defined as the time from the first dose of study drug to the first documentation of objective response (CR, PR, or MR) per modified RANO 2.0, assessed by BICR and by the Investigator | From the date of first dose of study drug to the first documentation of objective response (CR, PR, or MR), approximately 18 months |
| Overall Survival (OS) | OS, defined as the time from the first dose of study drug to death from any cause. | From the date of first dose of study drug until the date of death, approximately 18 months |
| Safety and tolerability | The safety and tolerability of safusidenib evaluated based on AEs graded by NCI-CTCAE version 5.0, laboratory abnormalities as graded by NCI-CTCAE version 5.0, vital signs, physical examinations, and ECGs | From the date of first dose of study drug until 30 days after the date of the last dose of study drug, approximately 18 months |
| Seizure Activity | Evaluate seizure frequencies and severity including type of seizure, seizure-related AEs, and changes in anti-epileptic medications in participants receiving safusidenib | From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D009837 | Oligodendroglioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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