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Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

Study acronym: SOLSTICE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Dec 31, 2025 to Dec 31, 2026 Secondary endpoints: 5 to 12v15 Show 1 more changeShow less
    • Secondary endpoints: 5 to 12

    See this version in full on ClinicalTrials.gov ↗

  2. Completion date: Jun 30, 2024 to Dec 31, 2025 Publications: details revised at 1 of 1 entryv14 Show 1 more changeShow less
    • Publications: details revised at 1 of 1 entry
  3. Study sites: 191 to 190v13
  4. Trial status: Completed to Active, Not Recruiting Enrollment target: 874 to 856 · Completion date: Oct 1, 2022 to Jun 30, 2024v12 Show 2 more changesShow less
    • Enrollment target: 874 to 856
    • Completion date: Oct 1, 2022 to Jun 30, 2024
  5. Study sites: 201 to 191v11
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Active, Not Recruiting to Completed Enrollment target: 856 to 874 · Primary completion date: Jun 9, 2021 to Jun 29, 2021 · Study completion date changed from estimate of Sep 18, 2022 to Oct 1, 2022v10 Show 3 more changesShow less
    • Enrollment target: 856 to 874
    • Primary completion date: Jun 9, 2021 to Jun 29, 2021
    • Study completion date changed from estimate of Sep 18, 2022 to Oct 1, 2022
  2. Primary completion date changed from estimate of Sep 18, 2022 to Jun 9, 2021v9
  3. 2 versions Re-verified since Dec 21, 2021, no change to tracked fieldsv7-v8
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 854 to confirmed 856 · Study sites: 167 to 201v6 Show 2 more changesShow less
    • Enrollment target: estimated 854 to confirmed 856
    • Study sites: 167 to 201
  5. Study sites: 133 to 167v5
  6. Study sites: 113 to 133 Primary and study completion dates: Sep 17, 2022 to Sep 18, 2022v4 Show 1 more changeShow less
    • Primary and study completion dates: Sep 17, 2022 to Sep 18, 2022
  7. Study sites: 33 to 113v3
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 94 to 33 · Start date changed from estimate of Mar 20, 2019 to Mar 21, 2019v2 Show 2 more changesShow less
    • Study sites: 94 to 33
    • Start date changed from estimate of Mar 20, 2019 to Mar 21, 2019
  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.
The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.
Trial Details
NCT Number NCT03869892
Lead Sponsor Institut de Recherches Internationales Servier
Collaborators: ADIR, a Servier Group company
Conditions Metastatic Colorectal Cancer
Enrollment 856 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov