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

StatusRecruiting
PhasePhase 4
SponsorTakeda
Started2025-01-14
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 13 times since 2024-08-16; most recent filed 2026-07-03. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-07-03
Amendment Study Status, Contacts/Locations, References v13
2026-05-19
Amendment Study Status, Contacts/Locations v12
2026-02-26
Amendment Study Status, Contacts/Locations v11
2026-01-02
Amendment Study Status, Contacts/Locations v10
2025-12-11
Amendment Study Status, Contacts/Locations v9
2025-11-17
Amendment Study Status, Contacts/Locations v8
2025-09-08
Amendment Study Status, Contacts/Locations v7
2025-08-14
Amendment Study Status, Contacts/Locations v6
2025-07-07
Amendment Study Status, Contacts/Locations v5
2025-06-24
Amendment Study Status, Contacts/Locations v4
2025-05-02
Amendment Study Status, Contacts/Locations v3
2025-04-28
Amendment Study Status, Contacts/Locations v2
2025-01-30
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v1
2024-08-16
Original filing
Trial Details
NCT Number NCT06562543
Lead Sponsor Takeda
Conditions Colorectal Cancer
Enrollment 78 participants
Start Date 2025-01-14
Primary Completion 2027-10-04 (estimated)
Study Completion 2027-10-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-07