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NCT06562543
A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
Conditions: Colorectal Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 78
Sponsor: Takeda
Location: Central Alabama Research Birmingham Alabama
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Provide written (or electronic) informed consent.
2. Male or female aged more than or equal to (≥)18 years.
3. Presence of histologically and/or cytologically documented metastatic colorectal adenocarcinoma. Rat sarcoma virus (RAS) status for each participant must be documented.
4. Have been previously treated with standard approved therapies:
* Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy,
* An anti-vascular endothelial growth factor (VEGF) biological therapy (e.g., bevacizumab, aflibercept, ramucirumab \[regorafenib is NOT an anti-VEGF biologic\]), and
* If RAS wild-type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy (e.g., cetuximab, panitumumab).
* If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor.
5. Self-identify as Black and/or African American or Hispanic and/or Latino or as both.
6. Body weight ≥40 kilograms (kg).
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.
8. Have assessable disease according to RECIST version 1.1, assessed locally.
9. In participants of childbearing potential, agreement to use highly effective form(s) of contraception, which results in a low failure rate (less than \[\
Source: ClinicalTrials.gov (NCT06562543). StuddyBuddy aggregates publicly available trial information.