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ONO-4538 Phase II Rollover Study (ONO-4538-98)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since May 2, 2024, no change to tracked fieldsv11-v12
  2. Study sites: 37 to 38 Interventions: ONO-4538 (Drug), S-1 (Drug), bevacizumab (Drug), capecitabine (Drug), oxaliplatin (Drug) to ONO-4538 (Drug), S-1 (Drug), bevacizumab (Drug), capecitabine (Drug), oxaliplatin (Drug), temozolomide (Drug)v10 Show 1 more changeShow less
    • Interventions: ONO-4538 (Drug), S-1 (Drug), bevacizumab (Drug), capecitabine (Drug), oxaliplatin (Drug) to ONO-4538 (Drug), S-1 (Drug), bevacizumab (Drug), capecitabine (Drug), oxaliplatin (Drug), temozolomide (Drug)
  3. Enrollment target: 33 to 59 Primary and study completion dates: Sep 30, 2025 to Dec 31, 2026 · Study sites: 22 to 37 · Interventions: ONO-4538 (Drug), S-1 (Drug), capecitabine (Drug), oxaliplatin (Drug) to ONO-4538 (Drug), S-1 (Drug), bevacizumab (Drug), capecitabine (Drug), oxaliplatin (Drug)v9 Show 3 more changesShow less
    • Primary and study completion dates: Sep 30, 2025 to Dec 31, 2026
    • Study sites: 22 to 37
    • Interventions: ONO-4538 (Drug), S-1 (Drug), capecitabine (Drug), oxaliplatin (Drug) to ONO-4538 (Drug), S-1 (Drug), bevacizumab (Drug), capecitabine (Drug), oxaliplatin (Drug)
  4. Enrollment target: 20 to 33 Study sites: 17 to 22 · Interventions: ONO-4538 (Drug) to ONO-4538 (Drug), S-1 (Drug), capecitabine (Drug), oxaliplatin (Drug) · Eligibility criteria expanded, about 12 words · 1 morev8 Show 4 more changesShow less
    • Study sites: 17 to 22
    • Interventions: ONO-4538 (Drug) to ONO-4538 (Drug), S-1 (Drug), capecitabine (Drug), oxaliplatin (Drug)
    • Eligibility criteria expanded, about 12 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 1 of 17 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 16 to 17v6
  2. Site details revised at 1 of 16 sitesv5
  3. Study sites: 14 to 16v4
  4. Site details revised at 7 of 14 sitesv3
  5. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.
Trial Details
NCT Number NCT04566380
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Pan-tumor
Enrollment 59 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov