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This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or astrocytoma) with an IDH1 mutation who have undergone surgery as their only treatment 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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| Placebo | Placebo Comparator | Placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safusidenib | Drug | Safusidenib administered twice daily as a single agent dosed orally on Days 1 through 28 of a 28-day cycle. Participants may continue treatment until disease progression or another reason for discontinuation occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 | PFS, defined as time from date of randomization to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR or death from any cause, whichever occurs earlier | From the date of randomization until the date of first documented disease progression, approximately 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) assessed by BICR per modified RANO 2.0 | 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 randomization until the date of first documented disease progression, approximately 30 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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Randomized, double-blind, placebo-controlled with the possibility for crossover for participants receiving placebo should they meet specific eligibility requirements.
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The Sponsor and Sponsor representatives (including the CRO) will be blinded to the treatment assignment.
| Placebo | Drug | Placebo administered twice daily as a single agent dosed orally on Days 1 through 28 of a 28-day cycle. Participants may continue treatment with placebo until disease progression or another reason for discontinuation occurs. |
|
| Time to Next Intervention (TTNI) | TTNI, defined as the time from randomization to the initiation of first subsequent anticancer therapy or death from any cause, whichever occurs earlier. | From the date of randomization until the date of the start of another anticancer treatment or date of death, approximately 30 months |
| PFS assessed by the Investigator per modified RANO 2.0 | PFS, defined as the time from date of randomization to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by the Investigator or death from any cause, whichever occurs earlier | From the date of randomization until the date of first documented disease progression, approximately 30 months |
| ORR assessed by the Investigator per modified RANO 2.0 | ORR, defined as the proportion of participants with the confirmed best overall response of CR, PR, and MR per modified RANO 2.0 as assessed by the investigator. | From the date of randomization until the date of the first documented disease progression, approximately 30 months |
| Duration of Response (DOR) assessed by BICR and by the Investigator per modified RANO 2.0 | DOR, the 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 or death from any cause, whichever occurs earlier, as assessed by BICR and by the Investigator. | From the date of randomization until the date of first documented disease progression, approximately 30 months |
| Time to Response (TTR) assessed by BICR and by the Investigator per modified RANO 2.0 | TTR, defined as the time from randomization to the first documentation of objective response (CR, PR, or MR) per modified RANO 2.0 assessed by BICR and by the Investigator. | From randomization to the first documentation of objective response (CR, PR, or MR), approximately 30 months |
| Disease Control Rate (DCR) assessed by BICR and by the Investigator per modified RANO 2.0 | DCR, defined as the proportion of participants with a best overall response of CR, PR, MR, or stable disease (SD) per modified RANO 2.0, as assessed by BICR and by the Investigator | From the date of randomization until the date of first documented disease progression, approximately 30 months |
| Tumor Growth Rate (TGR) by volume assessed 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 30 months |
| Overall Survival (OS) | OS, defined as the time from randomization to death from any cause | From the date of randomization until the date of death, approximately 30 months |
| Safety and tolerability | The safety and tolerability of safusidenib compared with placebo 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 first dose of study drug until 30 days after treatment discontinuation, approximately 30 months |
| Safusidenib PK Profile | Characterize the safusidenib concentrations | From the first dose of study drug through approximately 16 weeks |
| Health-Related Quality of Life | Evaluate health-related quality of life (HRQoL) with safusidenib compared with placebo assessed by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire scores. | From the first dose of study drug to treatment discontinuation, approximately 30 months |
| Health-Related Quality of Life | Evaluate health-related quality of life (HRQoL) with safusidenib compared with placebo assessed by the Quality of Life in Epilepsy (QOLIE-10-P) scores. | From the first dose of study drug to treatment discontinuation, approximately 30 months |
| Health-Related Quality of Life | Evaluate health-related quality of life (HRQoL) with safusidenib compared with placebo assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores. | From the first dose of study drug to treatment discontinuation, approximately 30 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 compared with placebo | From the date of randomization until the date of first documented disease progression, approximately 30 months |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| 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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