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A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Jun 27, 2026 → Dec 31, 2027
See other at-risk trials from Fore Biotherapeutics

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jun 27, 2026 to Dec 31, 2027
    • Study completion pushed from Dec 28, 2026 to Dec 28, 2028
    • Eligibility criteria expanded, about 8 words
    • Site details revised at 6 of 70 sites
    v28
  2. Minor Study sites: 69 to 70v27
  3. Minor Study sites: 67 to 69v26
  4. Minor Study sites: 66 to 67v25
  5. Minor Study sites: 64 to 66v24
Show 22 earlier versionsHide 22 earlier versions
  1. Minor Site details revised at 1 of 64 sitesv23
  2. Minor Study sites: 61 to 64v22
  3. Minor Study sites: 60 to 61v21
  4. Minor Enrollment target: 250 to 254v20 Show 4 more changesShow less
    • Interventions: Cobicistat (Drug), Plixorafenib (Drug) to Plixorafenib (Drug)
    • Eligibility criteria shortened, about 36 words
    • Secondary endpoints: 16 to 13
    • Site details revised at 6 of 60 sites
  5. Minor Study sites: 56 to 60v19
  6. Minor Study sites: 55 to 56v18
  7. Notable Primary completion date: Jun 27, 2025 to Jun 27, 2026v17 Show 4 more changesShow less
    • Study sites: 53 to 55
    • Study completion date: Aug 28, 2026 to Dec 28, 2026
    • Eligibility criteria shortened, about 672 words
    • Secondary endpoints: 15 to 16
  8. Minor Study sites: 52 to 53v16
  9. Minor Study sites: 48 to 52v15
  10. Notable Enrollment target: 135 to 250v14 Show 5 more changesShow less
    • Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 522 words
    • Secondary endpoints revised (15)
    • Site details revised at 5 of 48 sites
    • Study arms: 2 to 4
  11. Minor Study sites: 47 to 48v13
  12. Minor Study sites: 43 to 47v12
  13. Minor Study sites: 41 to 43v11
  14. Minor Study sites: 19 to 41
    • Interventions: Cobicistat (Drug), FORE8394 (Drug) to Cobicistat (Drug), Plixorafenib (Drug)
    • Eligibility criteria expanded, about 233 words
    • Secondary endpoints revised (15)
    v10
  15. Minor Study sites: 16 to 19v9
  16. Minor Study sites: 13 to 16v8
  17. Minor Study sites: 10 to 13v7
  18. Minor Study sites: 3 to 10v6
  19. Minor Start date changed from estimate of Mar 1, 2023 to Feb 21, 2023v5
  20. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 1, 2022 to Mar 1, 2023
    • Study sites: 0 to 3
    v4
  21. Notable Start date: Oct 1, 2022 to Nov 1, 2022
    • Primary completion date: Aug 27, 2025 to Jun 27, 2025
    • Study completion date: Sep 28, 2026 to Aug 28, 2026
    v3
  22. Notable Start date: Sep 1, 2022 to Oct 1, 2022v2
  1. Minor 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.
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and 3 more diseases
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors, including rare BRAF V600E-mutated solid tumors, including anaplastic thyroid, ovarian, cholangiocarcinoma or other rare cancers.
Trial Details
NCT Number NCT05503797
Lead Sponsor Fore Biotherapeutics
Conditions
(from sponsor)
Cancer Harboring BRAF Alterations, HGG, LGG, Solid Tumors
Related terms Biliary Tract Neoplasms, Breast Neoplasms, Carcinoma, Hepatocellular, Cholangiocarcinoma, Fallopian Tube Neoplasms, Gastrointestinal Stromal Tumors, Glioma, Ovarian Neoplasms, Thyroid Carcinoma, Anaplastic, Urinary Bladder Neoplasms, Uterine Neoplasms
Enrollment 254 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov