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A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Primary completion pushed from Mar 31, 2027 to May 28, 2027
    • Study completion date: Oct 31, 2029 to Oct 9, 2029
    • Study sites revised (3)
    v7
  3. Sponsor changed: SpringWorks Therapeutics, Inc. to SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germanyv6
  4. Re-verified, no change to tracked fieldsv5
  5. Primary completion moved earlier from May 31, 2028 to Mar 31, 2027v4 Show 4 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment increased: 18 → 20 participants
    • Study completion moved earlier from Dec 31, 2030 to Oct 31, 2029
    • Site details revised at 3 of 3 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Study sites: 2 to 3v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is being conducted to characterize the efficacy and safety of nirogacestat in Japanese adults with progressing desmoid tumors/aggressive fibromatosis.
Trial Details
NCT Number NCT07170644
Lead Sponsor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Conditions
(from sponsor)		 Desmoid Tumor, Aggressive Fibromatosis
Related terms Desmoid Tumors
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov