SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

Conditions

• Astrocytoma, Grade IV
• Astrocytoma, IDH-Mutant, Grade 2
• Astrocytoma, IDH-Mutant, Grade 3
• Astrocytoma, IDH-Mutant, Grade 4
• Glioma
• IDH1-mutant Glioma
• Oligodendroglioma
• Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• safusidenib — DRUG
  safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.
• Placebo — DRUG
  Placebo administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with placebo until disease progression or another reason for discontinuation occurs.

Study Details

This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.

Key Dates

Start date

Jun 5, 2023

Status verified

Mar 2026

Primary completion

Dec 1, 2028

Completion

Dec 1, 2030

Study Design

Enrollment

365 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: safusidenib 125mg bid (part 1)
  safusidenib 125mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
• Experimental: safusidenib 250mg bid (part 1)
  safusidenib 250mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
• Experimental: safusidenib 500mg qd (part 1)
  safusidenib 500mg qd administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
• Experimental: safusidenib 375mg bid (part 1)
  safusidenib 375mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
• Experimental: safusidenib 500mg bid (part 1)
  safusidenib 500mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.
• Experimental: safusidenib 250mg bid (Part 2)
  safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment until disease progression or another reason for discontinuation occurs.
• Placebo Comparator: placebo (Part 2)
  Placebo administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with placebo until disease progression or another reason for discontinuation occurs.
• Experimental: safusidenib 250mg bid (Part 3)
  safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment until disease progression or another reason for discontinuation occurs.

Primary Outcome Measure

Part 1: Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From participants sign ICF to 30 days after last dose，average 2 years ]

Central Contacts

• Clinical Trials at Nuvation Bio
  332-208-6102
  [email protected]

Locations (40)

Find similar trials in Birmingham, AL

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