Fruquintinib for Colorectal Cancer

Recruiting at 39 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Takeda

Must not be taking: Anticoagulants, TKIs, CYP3A4 inducers

Disqualifiers: Uncontrolled hypertension, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Variable (until progression or discontinuation)

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on how often individuals from minority groups, specifically Black/African American or Hispanic/Latino, experience high blood pressure when treated with fruquintinib for advanced colorectal cancer. The trial also assesses the safety and manageability of the treatment for participants. Suitable candidates have previously received treatment for metastatic colorectal cancer and identify as Black/African American or Hispanic/Latino. Participants will take fruquintinib in 4-week cycles until their cancer progresses or they can no longer tolerate the treatment. As a Phase 4 trial, this research examines how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot use certain therapies like systemic antineoplastic therapies or strong inducers of CYP3A4 within a specified period before starting the trial.

What is the safety track record for fruquintinib?

Research has shown that fruquintinib is generally safe and manageable for patients with hard-to-treat metastatic colorectal cancer (mCRC). In a study of 278 patients, high blood pressure was the most common serious side effect, affecting about 21.2% of participants. This finding indicates that while high blood pressure is a significant side effect, it can usually be controlled. Overall, fruquintinib is well-tolerated, meaning most patients can handle the treatment effectively. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Fruquintinib is unique because it specifically targets the VEGFR family of receptors, which play a crucial role in tumor blood vessel growth, making it different from traditional chemotherapy treatments for colorectal cancer. Unlike standard chemotherapy that affects both healthy and cancerous cells, fruquintinib offers a more targeted approach, potentially reducing side effects and improving patient outcomes. Researchers are excited about fruquintinib because it promises a more precise mechanism of action, offering hope for more effective and tolerable treatment options for individuals battling colorectal cancer.

What is the effectiveness track record for fruquintinib in treating colorectal cancer?

Research has shown that fruquintinib can help treat hard-to-treat metastatic colorectal cancer (mCRC). In one study, patients taking fruquintinib lived for an average of 7.4 months after starting the treatment. Another study found that 64.8% of patients experienced disease control, meaning their cancer did not worsen for a while. Fruquintinib also helped patients live longer without disease progression. This trial will evaluate fruquintinib at a dose of 5 mg, taken orally once daily for the first 21 days of each 28-day treatment cycle, to further assess its potential in extending life and controlling cancer growth. ^{5 6 7 8 9}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

This trial is for adults over 18 who self-identify as Black/African American or Hispanic/Latino with advanced colorectal cancer that has spread and didn't respond to standard treatments. They must be able to perform daily activities with ease (ECOG status 0-1) and weigh at least 40 kg. Participants need documented RAS status, have tried specific chemotherapies and biological therapies, and if applicable, PD1 inhibitors or anti-EGFR therapy.

Inclusion Criteria

I weigh at least 40 kg.

I am fully active or can carry out light work.

My cancer is RAS wild-type and suitable for anti-EGFR therapy like cetuximab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fruquintinib in 4-week treatment cycles until progressive disease, unacceptable toxicity, or other discontinuation criteria are met

Variable (until progression or discontinuation)

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with checks every 3 months until study completion

Approximately 35 months

Quarterly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fruquintinib

Trial Overview

The study tests the safety and effect of Fruquintinib on blood pressure in minority populations with metastatic colorectal cancer resistant to previous treatments. Patients will take Fruquintinib in cycles of four weeks until their disease progresses, side effects become intolerable, or they choose to stop treatment.

How Is the Trial Designed?

Group I: Fruquintinib 5 mg Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Published Research Related to This Trial

In a phase 3 study involving 691 patients with advanced, chemotherapy-refractory colorectal cancer, fruquintinib significantly improved overall survival, with a median of 7.4 months compared to 4.8 months for the placebo group (hazard ratio 0.66, p<0.0001).

While fruquintinib showed efficacy, it also had a higher incidence of grade 3 or worse adverse events (63% in the fruquintinib group vs. 50% in the placebo group), with hypertension being the most common side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Dasari, A., Lonardi, S., Garcia-Carbonero, R., et al.[2023]

Fruquintinib is a highly selective oral inhibitor of VEGFR1, 2, and 3 tyrosine kinases, effectively blocking VEGF-induced signaling that promotes cancer cell growth and blood vessel formation.

It has been approved in China for treating metastatic colorectal cancer in patients who have not responded to at least two previous therapies, although it is not yet approved in other countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fruquintinib and its use in the treatment of metastatic colorectal cancer. Deng, Y., Li, X.[2022]

In a study of 45 patients with refractory metastatic colorectal cancer (mCRC), the combination of fruquintinib and various PD-1 inhibitors showed clinical activity, with an overall response rate of 11.1% and a disease control rate of 62.2%.

The median overall survival was 14.9 months, and no adverse-effect-related deaths were reported, suggesting that this treatment combination is safe for heavily pretreated patients, although further research is needed to confirm these findings in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fruquintinib in Combination With PD-1 Inhibitors in Patients With Refractory Non-MSI-H/pMMR Metastatic Colorectal Cancer: A Real-World Study in China. Gou, M., Qian, N., Zhang, Y., et al.[2022]

In a study of 366 patients with metastatic colorectal cancer, regorafenib and fruquintinib showed similar efficacy in terms of time-to-treatment failure and overall survival, indicating that both treatments are viable options for patients.

Patients who received regorafenib followed by fruquintinib had a longer overall survival (28.1 months) compared to those who received the treatments in the reverse order (18.4 months), suggesting a potential benefit in treatment sequencing that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety Comparison of Regorafenib and Fruquintinib in Metastatic Colorectal Cancer-An Observational Cohort Study in the Real World. Zhang, Q., Chen, M., Wang, Z., et al.[2022]

Regorafenib and fruquintinib are effective and well-tolerated third-line treatment options for metastatic colorectal cancer (mCRC), as supported by a review of clinical studies.

Both drugs have similar survival outcomes, but regorafenib demonstrates a slightly better toxicity profile, making it a preferable choice in terms of safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review. Xu, X., Yu, Y., Liu, M., et al.[2022]

In a real-world study of 75 patients with metastatic colorectal cancer, fruquintinib demonstrated a median progression-free survival of 5.4 months, indicating its efficacy as a treatment option.

The treatment was generally safe, with only 6% of patients experiencing grade 3 adverse events, which included manageable side effects like hand-foot skin reaction and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Data: Fruquintinib in Treating Metastatic Colorectal Cancer. Liu, S., Lu, L., Pan, F., et al.[2022]

In the FRESCO study, fruquintinib significantly improved overall survival (OS) and progression-free survival (PFS) in metastatic colorectal cancer patients, regardless of whether they had prior targeted therapy (PTT).

The safety profile of fruquintinib was consistent across both subgroups, with similar rates of treatment-emergent adverse events (TEAEs), indicating that it is a well-tolerated option for patients with or without prior targeted treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subgroup analysis by prior anti-VEGF or anti-EGFR target therapy in FRESCO, a randomized, double-blind, Phase III trial. Xu, R., Qin, S., Guo, W., et al.[2022]

In the FRESCO trial involving Chinese patients with metastatic colorectal cancer, fruquintinib showed a significant overall survival benefit, with 95.7% of patients experiencing at least one treatment-related adverse event (TEAE).

The most common severe treatment-related adverse events (grade ≥3) included hypertension (21.2%), hand-foot skin reaction (10.8%), and proteinuria (3.2%), with similar frequencies observed across different age, sex, and BMI subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of the Phase 3 FRESCO Trial. Li, J., Guo, W., Bai, Y., et al.[2022]

Fruquintinib, a VEGFR inhibitor, significantly improved progression-free survival (PFS) by 3.7 months in metastatic colorectal cancer patients compared to placebo, demonstrating its efficacy in treatment-refractory cases.

The safety profile of fruquintinib was consistent with other VEGFR tyrosine kinase inhibitors, with common severe side effects including hypertension and hand-foot skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of fruquintinib in patients with previously treated metastatic colorectal cancer: a phase Ib study and a randomized double-blind phase II study. Xu, RH., Li, J., Bai, Y., et al.[2022]

Fruquintinib is a newly approved, highly selective inhibitor of VEGFRs that shows strong efficacy and low off-target toxicity in treating metastatic colorectal cancer (CRC) patients who have not responded to standard therapies.

It is suggested that fruquintinib could serve as a third-line treatment option for CRC and may be effectively combined with other targeted therapies to overcome drug resistance during long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical application of fruquintinib on colorectal cancer. Chen, Z., Jiang, L.[2022]

Fruquintinib is a selective tyrosine kinase inhibitor targeting VEGF receptors, approved in China for metastatic colorectal cancer, and is currently being tested in the global FRESCO-2 Phase III study involving approximately 687 patients.

The study aims to evaluate the efficacy and safety of fruquintinib compared to placebo, focusing on overall survival and progression-free survival in patients who have not responded to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FRESCO-2: a global Phase III study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer. Dasari, A., Sobrero, A., Yao, J., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11859084/

Clinical Progress of Fruquintinib in Colorectal Cancer

According to a systematic review and meta-analysis, the one-, three-, and five-year survival rates of CRC patients were 79%, 72%, and 62%, ...

2.

onclive.com

onclive.com/view/fruquintinib-efficacy-data-support-its-use-in-the-third-line-advanced-crc-setting

Fruquintinib Efficacy Data Support Its Use in the Third-Line ...

In the phase 3 FRESCO-2 trial (NCT04322539), the median OS was 7.4 months (95% CI, 6.7-8.2) with fruquintinib plus best supportive care (BSC; n ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e23317

Real-world evidence of fruquintinib (Fruq) efficacy after ...

The data suggest flexibility in treatment choices, with Fruquintinib showing improved OS when used earlier in the treatment sequence. These ...

4.

esmogastro.org

esmogastro.org/article/S2949-8198(25)00074-3/fulltext

Analysis of fruquintinib in patients with metastatic colorectal ...

Fruquintinib improved OS and PFS versus placebo in patients with refractory mCRC. ... Grade ≥3 TEAEs occurred in 60% versus 47% of patients ( ...

5.

esmoopen.com

esmoopen.com/article/S2059-7029(24)01471-6/fulltext

Fruquintinib in refractory metastatic colorectal cancer

Disease control was achieved in 337 (64.8%) of the 520 patients. Fruquintinib exhibited a median PFS (mPFS) of 5.0 months (95% CI 4.33-5.82 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40163688/

Fruquintinib versus placebo in patients with refractory ...

Fruquintinib + BSC demonstrated a predictable and manageable safety profile in pretreated patients with mCRC and is a novel oral treatment ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0273230025002053

Real-World Safety of Fruquininib in Refractory metastatic ...

In the FRESCO trial, among 278 patients treated with fruquintinib, the most common grade 3-4 AEs were hypertension (n=59, 21.2%), palmar-plantar ...

8.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3571

Efficacy and safety of fruquintinib plus investigator's choice ...

ORR was 26.0% (95%CI, 17.9-36.2), DoR was 11.3 mo (95%CI, 8.6-14.0), and DCR was 83.3% (95%CI, 74.0-89.9) in 96 efficacy-evaluable pts. The ...

9.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1590782/full

Efficacy and safety of fruquintinib in the treatment ...

This meta-analysis of 11 studies confirmed that fruquintinib significantly improved OS and PFS in colorectal cancer patients without increasing the incidence ...