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Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Site contact updatedv9
  2. Primary completion date: Feb 2026 to Dec 2026v8
  3. 2 versions Re-verified since Nov 8, 2024, no change to tracked fieldsv6-v7
  4. Primary endpoints: 2 to 3v5 Show 5 more changesShow less
    • Enrollment target: 86 to 111
    • Eligibility criteria shortened, about 238 words
    • Secondary endpoints: 8 to 10
    • Study description expanded, about 63 words
    • Study title expanded, about 3 words
  5. Enrollment target: 49 to 86v4 Show 8 more changesShow less
    • Primary completion date: Feb 2024 to Feb 2026
    • Primary endpoints: 1 to 2
    • Study completion date: Feb 2025 to Feb 2027
    • Interventions: Cabozantinib (Drug) to Cabozantinib (Drug), Nivolumab (Drug)
    • Eligibility criteria expanded, about 147 words
    • Secondary endpoints: 2 to 8
    • Study description expanded, about 101 words
    • Study arms: 1 to 2
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Secondary endpoints: details revised at 2 of 2 entries
    • Study title shortened, about 2 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a multi-site, three-cohort phase II trial of cabozantinib for IMDC all-risk frontline metastatic renal cell carcinoma (mRCC) patients OR any line mRCC patients who have not previously been treated with cabozantinib, and patients with pancreatic or extra-pancreatic neuroendocrine tumors.
Trial Details
NCT Number NCT05263050
Lead Sponsor Fox Chase Cancer Center
Collaborators: Exelixis
Conditions
(from sponsor)		 Metastatic Renal Cell Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma, Neuroendocrine Tumors, Carcinoid Tumor
Related terms Carcinoid Tumor, Carcinoma, Renal Cell, Clear-cell metastatic renal cell carcinoma, Neuroendocrine Tumors
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov