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SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

Study acronym: SIGMA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 57 → 61 locationsv38
  2. Study sites: 55 to 57v37
  3. Trial sites expanded: 45 → 55 locationsv36
  4. Site details revised at 3 of 45 sitesv35
  5. Site details revised at 1 of 45 sitesv34
Show 32 earlier versionsHide 32 earlier versions
  1. Re-verified, no change to tracked fieldsv33
  2. Phase: Phase 2 to Phase 3 Enrollment target: 125 to 365 · Primary completion date: Dec 1, 2027 to Dec 1, 2028 · Primary endpoints: 2 to 3 · 7 morev32 Show 10 more changesShow less
    • Enrollment target: 125 to 365
    • Primary completion date: Dec 1, 2027 to Dec 1, 2028
    • Primary endpoints: 2 to 3
    • Completion date: Mar 1, 2028 to Dec 1, 2030
    • Eligibility criteria expanded, about 211 words
    • Secondary endpoints: 23 to 34
    • Study description expanded, about 63 words
    • Site contacts updated at 1 of 45 sites
    • Study arms: 7 to 8
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites revised (45)v31 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 2 of 45 sitesv30
  5. Study sites: 40 to 45v29
  6. Site details revised at 1 of 40 sitesv28
  7. Site details revised at 3 of 40 sitesv27
  8. Site details revised at 4 of 40 sitesv26
  9. Site details revised at 2 of 40 sitesv25
  10. Site details revised at 5 of 40 sitesv24
  11. Study sites: 31 to 40v23
  12. Study sites revised (31)v22 See this version in full on ClinicalTrials.gov ↗
  13. Site details revised at 1 of 31 sitesv21
  14. Site details revised at 1 of 31 sitesv20
  15. Site details revised at 1 of 31 sitesv19
  16. Site details revised at 2 of 31 sitesv18
  17. Site details revised at 1 of 31 sitesv17
  18. Site details revised at 1 of 31 sitesv16
  19. Site details revised at 3 of 31 sitesv15
  20. Site details revised at 2 of 31 sitesv14
  21. Study sites: 10 to 31v13
  22. Study sites: 9 to 10v12
  23. Site details revised at 3 of 9 sitesv11
  24. Site details revised at 1 of 9 sitesv10
  25. Site details revised at 2 of 9 sitesv9
  26. Site details revised at 1 of 9 sitesv8
  27. Trial status: Active, Not Recruiting to Recruiting Site details revised at 9 of 9 sitesv7 Show 1 more changeShow less
    • Site details revised at 9 of 9 sites
  28. Primary completion date: Mar 31, 2027 to Dec 1, 2027 Primary endpoints revised (2) · Enrollment target: 95 to 125 · Completion date: Jul 31, 2027 to Mar 1, 2028 · 5 morev6 Show 8 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 95 to 125
    • Completion date: Jul 31, 2027 to Mar 1, 2028
    • Interventions: safusidenib (Drug) to Placebo (Drug), safusidenib (Drug)
    • Eligibility criteria shortened, about 365 words
    • Secondary endpoints: 24 to 23
    • Study description expanded, about 184 words
    • Study arms: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  29. Lead sponsor: AnHeart Therapeutics Inc. to Nuvation Bio Inc. Trial status: Recruiting to Active, Not Recruiting · Site details revised at 9 of 9 sites · Collaborators expanded, about 3 wordsv5 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  30. Study sites: 1 to 9 Start date changed from estimate of May 26, 2023 to Jun 5, 2023v4 Show 1 more changeShow less
    • Start date changed from estimate of May 26, 2023 to Jun 5, 2023
  31. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jan 2026 to Mar 31, 2027 · Start date: Jan 2023 to May 26, 2023 · Enrollment target: 114 to 95 · 6 morev3 Show 9 more changesShow less
    • Primary completion date: Jan 2026 to Mar 31, 2027
    • Start date: Jan 2023 to May 26, 2023
    • Enrollment target: 114 to 95
    • Study sites: 0 to 1
    • Completion date: Feb 2027 to Jul 31, 2027
    • Interventions: AB-218 (Drug) to safusidenib (Drug)
    • Eligibility criteria shortened, about 58 words
    • Secondary endpoints revised (24)
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  32. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Nuvation Bio
10 trials monitored
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Glioblastoma
670 trials monitored
See 44 trials at risk
Glioma
668 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT05303519
Lead Sponsor Nuvation Bio Inc.
Collaborators: AnHeart Therapeutics Inc.
Conditions Glioma, Astrocytoma, Grade IV, IDH1-mutant Glioma, Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4, Astrocytoma, IDH-Mutant, Grade 2, Oligodendroglioma, Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted
Enrollment 365 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov