A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

Study acronym: PIKASSO-01
StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Primary endpoints: details revised at 2 of 2 entries Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion date changed from estimate of Dec 2026 to Apr 2, 2025
    • Eligibility criteria expanded, about 45 words
    • Site details revised at 50 of 50 sites
  2. Site details revised at 4 of 50 sitesv47
  3. Site details revised at 6 of 50 sitesv46
  4. Trial status changed: Active, Not Recruiting → Recruiting
    • Enrollment increased: 193 → 260 participants
    • Site details revised at 50 of 50 sites
    v45
  5. Trial sites expanded: 45 → 50 locationsv44
Show 42 earlier versionsHide 42 earlier versions
  1. Study sites: 50 to 45v43
  2. Re-verified, no change to tracked fieldsv42
  3. Primary and study completion dates: Dec 2025 to Dec 2026v41
  4. 3 versions Re-verified since Oct 15, 2025, no change to tracked fieldsv38-v40
  5. Site details revised at 20 of 50 sitesv37
  6. Re-verified, no change to tracked fieldsv36
  7. Primary completion date: May 2025 to Dec 2025
    • Study sites: 55 to 50
    v35
  8. Study completion date: May 2025 to Dec 2025
    • Study sites revised (55)
    v34
  9. Re-verified, no change to tracked fieldsv33
  10. Collaborators shortened, about 3 wordsv32
  11. Re-verified, no change to tracked fieldsv31
  12. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 400 to confirmed 193
    • Site details revised at 55 of 55 sites
    v30
  13. Re-verified, no change to tracked fieldsv29
  14. Site details revised at 1 of 55 sitesv28
  15. Study sites: 48 to 55v27
  16. Study sites: 44 to 48v26
  17. Study sites: 41 to 44v25
  18. Study sites: 39 to 41v24
  19. Study sites: 35 to 39v23
  20. Study sites: 33 to 35v22
  21. Study sites: 31 to 33v21
  22. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 10 entries
    v20
  23. Study sites: 24 to 31v19
  24. Study sites: 23 to 24v18
  25. Study sites: 21 to 23v17
  26. Study sites: 20 to 21v16
  27. Study sites: 14 to 20v15
  28. Enrollment target: 300 to 400
    • Eligibility criteria expanded, about 34 words
    • Study arms: 6 to 7
    v14
  29. Study sites: 12 to 14v13
  30. Study sites: 11 to 12v12
  31. Re-verified, no change to tracked fieldsv11
  32. Study sites: 10 to 11v10
  33. Study sites: 8 to 10v9
  34. Study sites: 7 to 8v8
  35. Enrollment target: 260 to 300
    • Study sites: 5 to 7
    • Eligibility criteria expanded, about 9 words
    v7
  36. Re-verified, no change to tracked fieldsv6
  37. Study sites: 4 to 5v5
  38. Site contacts updated at 4 of 4 sitesv4
  39. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Apr 2022 to May 11, 2022
    v3
  40. Study Status, Referencesv2
  1. Study First Submitted
  • 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.
Eli Lilly
363 trials monitored
See 16 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
Trial Details
NCT Number NCT05307705
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov