Cabozantinib in High Grade Neuroendocrine Neoplasms

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Primary completion date changed from estimate of Sep 30, 2026 to Jul 27, 2026
  2. Eligibility criteria expanded, about 45 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Publications: details revised at 1 of 1 entry
  3. Primary completion date: Mar 31, 2026 to Sep 30, 2026
    • Study completion date: Sep 30, 2026 to Mar 31, 2027
    v15
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jul 31, 2026 to Mar 31, 2026
    • Study completion date: Mar 31, 2027 to Sep 30, 2026
    • Site details revised
    v14
  5. Primary completion date: Dec 31, 2025 to Jul 31, 2026
    • Study completion date: Aug 31, 2026 to Mar 31, 2027
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Enrollment target: 32 to 35v12
  2. Primary completion date: Jul 31, 2025 to Dec 31, 2025
    • Study completion date: Mar 31, 2026 to Aug 31, 2026
    v11
  3. Primary completion date: Nov 30, 2024 to Jul 31, 2025
    • Study completion date: Jul 31, 2025 to Mar 31, 2026
    v10
  4. Eligibility criteria shortened, about 9 words
    • Site contact updated
    v9
  5. Primary completion date: Mar 31, 2024 to Nov 30, 2024
    • Study completion date: Nov 30, 2024 to Jul 31, 2025
    v8
  6. Re-verified, no change to tracked fieldsv7
  7. Eligibility criteria shortened, about 71 words
    • Site contact updated
    v6
  8. Interventions: Blood for plasma biomarkers (Procedure), Cabozantinib (Drug) to Blood for plasma biomarkers (Procedure), Cabozantinib (Drug), Tissue biopsy (Procedure)
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 1 of 3 entries
    v5
  9. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Apr 30, 2024 to Mar 31, 2024
    • Study completion date: Dec 31, 2024 to Nov 30, 2024
    • Start date changed from estimate of Dec 31, 2020 to Nov 24, 2020
    • Site details revised
  10. Start date: Sep 30, 2020 to Dec 31, 2020
    • Primary completion date: Jan 31, 2024 to Apr 30, 2024
    • Study completion date: Sep 30, 2024 to Dec 31, 2024
    v3
  11. Start date: Aug 31, 2020 to Sep 30, 2020v2 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2023 to Jan 31, 2024
    • Study completion date: Aug 31, 2024 to Sep 30, 2024
    • Eligibility criteria expanded, about 16 words
    • Site contact updated
  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.
High grade neuroendocrine neoplasm patients are treated with platinum doublets such as carboplatin and etoposide mimicking the current guidelines for small cell lung cancer (SCLC). Unfortunately, recurrences are common and most patients with metastatic disease succumb to it within a year. There is no extensive literature or consensus on second- or third-line options (which include FOLFOX, FOLFIRI, capecitabine and temozolomide, taxanes or immunotherapy) and there is urgent need for better regimens.
Trial Details
NCT Number NCT04412629
Lead Sponsor Washington University School of Medicine
Collaborators: Exelixis
Conditions
(from sponsor)		 High Grade Neuroendocrine Neoplasms
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov