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

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fruquintinib — DRUG
  Oral capsules

Study Details

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.

Key Dates

Start date

Jan 14, 2025

Status verified

May 2026

Primary completion

Oct 4, 2027

Completion

Oct 4, 2027

Study Design

Enrollment

78 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Fruquintinib 5 mg
  Participants will receive fruquintinib capsule at a dose of 5 mg, orally (PO), once daily (QD), for the first 21 days of each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or other discontinuation criteria are met.

Primary Outcome Measure

Number of Participants with Treatment Emergent Grade 3 and Grade 4 Hypertension [ Time Frame: From the first dose of the study drug up to end of study (approximately 35 months) ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (44)

Find similar trials in Birmingham, AL

Related Studies

• Evaluation for NCI Surgery Branch Clinical Research Protocols
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients
  Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee
• ColoCare Study - Colorectal Cancer Cohort
  Recruiting · University of Utah · Los Angeles, California
• Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
  PHASE1/PHASE2 · Recruiting · Lumicell, Inc. · Boston, Massachusetts