A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
NCT Number: NCT06562543
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Colorectal Cancer
Interventions: DRUG: Fruquintinib
Sponsor: Takeda
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-20
Completion Date: 2028-02-18

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.

Primary Outcome Measures: Number of Participants with Treatment Emergent Grade 3 and Grade 4 Hypertension, A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving the first dose of the study drug and within 30 days after the last dose of the study drug or the initiation of subsequent anti-cancer therapy, whichever occurs earlier. Severity (toxicity grade) for hypertension will be determined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0., From the first dose of the study drug up to end of study (approximately 35 months)
Secondary Outcome Measures: Number of Participants with TEAEs, Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and Deaths, An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of the trial intervention. It does not necessarily have to have a causal relationship with trial intervention. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An AESI is an AE of scientific and medical concern (including palmar-plantar erythrodysesthesia syndrome \[hand-foot syndrome\]) specific to the study drug or the same class of drugs (vascular endothelial growth factor \[VEGF\] inhibitors) for which ongoing monitoring and rapid communication by the investigator to Takeda may be appropriate. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered medically significant event., From the first dose of the study drug up to end of study (approximately 35 months)|Overall Survival (OS), OS will be defined as the interval from the first dose of fruquintinib until death., Up to approximately 35 months|Progression Free Survival (PFS), PFS will be defined as the interval from the first dose of fruquintinib until the first radiographic documentation of objective progression assessed by investigator using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or death from any cause., Up to approximately 35 months|Confirmed Objective Response Rate (cORR), Confirmed ORR is defined as the percentage of participants achieving a best overall response of confirmed complete response (CR) or partial response (PR), assessed by investigator per RECIST version 1.1. To be qualified for stable disease (SD), the duration of SD should last for at least 7 weeks., Up to approximately 35 months|Disease Control Rate (DCR), DCR is defined as the percentage of participants achieving a best overall response of confirmed CR, PR, or SD, as assessed by investigator per RECIST version 1.1., Up to approximately 35 months|Duration of Response (DOR), DOR is defined as the interval from the first occurrence of PR or CR, whichever comes first, until the date of radiographic PD or death. DOR will be determined for participants with the best overall response of confirmed CR or PR as assessed by investigator per RECIST version 1.1., Up to approximately 35 months|Plasma Concentration for Fruquintinib, Pre-dose (within 1 hour) on Day 21 of Cycles 1 and 2; 2 hours post-dose on Days 1 and 21 of Cycles 1 to 4 and 3 hours post-dose on Days 1 and 21 of Cycles 1 and 2 (cycle length=28 days)