A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer

StatusRecruiting
PhasePhase 4
SponsorTakeda
Started

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Record History

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  1. Minor Site details revised at 1 of 45 sitesv14
  2. Minor Site details revised at 3 of 45 sitesv13
  3. Minor Study sites revised (45)v12
  4. Minor Study sites revised (45)v11
  5. Minor Site details revised at 7 of 45 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Site details revised at 1 of 45 sitesv9
  2. Minor Site details revised at 1 of 45 sitesv8
  3. Minor Site details revised at 3 of 45 sitesv7
  4. Minor Site details revised at 2 of 45 sitesv6
  5. Minor Site details revised at 11 of 45 sitesv5
  6. Minor Site details revised at 6 of 45 sitesv4
  7. Minor Study sites: 39 to 45
    • Primary and study completion dates: Feb 18, 2028 to Oct 4, 2027
    • Start date: Jan 20, 2025 to Jan 14, 2025
    v3
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 39
    • Start date changed from estimate of Dec 20, 2024 to Jan 20, 2025
    v2
  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.
222 trials monitored
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High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants. Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion.
Trial Details
NCT Number NCT06562543
Lead Sponsor Takeda
Conditions
(from sponsor)
Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov