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A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation

Study acronym: RAMP 201
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 71 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Dec 2024 to Nov 15, 2024v71
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 47 of 47 sitesv70 Show 1 more changeShow less
    • Site details revised at 47 of 47 sites
  3. Primary endpoints revised (4)v69 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion date: Dec 2023 to Dec 2024 Primary endpoints: 3 to 4 · Enrollment target: 184 to 225 · Completion date: Dec 2025 to Dec 2026 · 2 morev68 Show 5 more changesShow less
    • Primary endpoints: 3 to 4
    • Enrollment target: 184 to 225
    • Completion date: Dec 2025 to Dec 2026
    • Study arms: 3 to 4
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Jun 2023 to Dec 2023v67
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (47)v66 See this version in full on ClinicalTrials.gov ↗
  2. Enrollment target: 100 to 184 Primary endpoints: 2 to 3 · Interventions: avutometinib (VS-6766) (Drug), avutometinib (VS-6766) and Defactinib (Drug) to avutometinib (VS-6766) (Drug), avutometinib (VS-6766) and defactinib (Drug) · Study arms: 2 to 3v65 Show 3 more changesShow less
    • Primary endpoints: 2 to 3
    • Interventions: avutometinib (VS-6766) (Drug), avutometinib (VS-6766) and Defactinib (Drug) to avutometinib (VS-6766) (Drug), avutometinib (VS-6766) and defactinib (Drug)
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  3. Site contacts updated at 1 of 47 sitesv64
  4. Site contacts updated at 5 of 47 sitesv63
  5. Primary endpoints revised (2) Study sites: 45 to 47 · Interventions: VS-6766 (Drug), VS-6766 and Defactinib (Drug) to avutometinib (VS-6766) (Drug), avutometinib (VS-6766) and Defactinib (Drug) · Study title revised · 1 morev62 Show 4 more changesShow less
    • Study sites: 45 to 47
    • Interventions: VS-6766 (Drug), VS-6766 and Defactinib (Drug) to avutometinib (VS-6766) (Drug), avutometinib (VS-6766) and Defactinib (Drug)
    • Study title revised
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv61
  7. Site details revised at 2 of 45 sitesv60
  8. Study sites: 42 to 45v59
  9. Site details revised at 2 of 42 sitesv58
  10. Study sites: 40 to 42v57
  11. Study sites: 38 to 40v56
  12. Site details revised at 2 of 38 sitesv55
  13. Study sites: 37 to 38v54
  14. Study sites: 36 to 37v53
  15. Study sites: 37 to 36v52
  16. Site details revised at 2 of 37 sitesv51
  17. Study sites: 36 to 37v50
  18. Study sites: 34 to 36v49
  19. Site details revised at 1 of 34 sitesv48
  20. Site details revised at 2 of 34 sitesv47
  21. Study sites: 33 to 34v46
  22. Study sites: 30 to 33v45
  23. Site contacts updated at 1 of 30 sitesv44
  24. Site contacts updated at 1 of 30 sitesv43
  25. Site details revised at 1 of 30 sitesv42
  26. Study sites: 29 to 30v41
  27. Study sites: 28 to 29v40
  28. Study sites: 27 to 28v39
  29. Site details revised at 2 of 27 sitesv38
  30. Site details revised at 1 of 27 sitesv37
  31. Study sites: 26 to 27v36
  32. Site contacts updated at 1 of 26 sitesv35
  33. Study sites: 24 to 26v34
  34. Site details revised at 2 of 24 sitesv33
  35. Site details revised at 1 of 24 sitesv32
  36. Study sites: 23 to 24v31
  37. Eligibility criteria expanded, about 2 wordsv30 See this version in full on ClinicalTrials.gov ↗
  38. Site details revised at 1 of 23 sitesv29
  39. Site details revised at 1 of 23 sitesv28
  40. Site details revised at 2 of 23 sitesv27
  41. Site details revised at 2 of 23 sitesv26
  42. Site details revised at 1 of 23 sitesv25
  43. Site details revised at 1 of 23 sitesv24
  44. Study sites: 22 to 23v23
  45. Study sites: 23 to 22v22
  • 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 will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Trial Details
NCT Number NCT04625270
Lead Sponsor Verastem, Inc.
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Conditions Low Grade Ovarian Serous Adenocarcinoma, Ovarian Cancer
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov