Fruquintinib + Lonsurf for Colorectal Cancer

(FRUITION Trial)

Recruiting at 1 trial location

Overseen By Julee Hartwell

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Criterium, Inc.

Must not be taking: QT prolongation drugs, CYP3A inducers

Disqualifiers: MSI-high, BRAF V600, CNS metastases, 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: 24 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining Fruquintinib with Lonsurf (also known as TAS-102, a chemotherapy drug) is more effective than using Fruquintinib alone for individuals with colorectal cancer unresponsive to other treatments. It targets patients with advanced or metastatic colorectal cancer that is "microsatellite stable" (a form lacking specific genetic instability). This trial may suit those who have not benefited from treatments like fluoropyrimidine, oxaliplatin, and irinotecan. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not clearly specify if you need to stop taking your current medications. However, you must stop medications that can cause QT prolongation (a heart rhythm condition) and certain drugs that affect liver enzymes (CYP3A inducers) at least 7 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining Fruquintinib with TAS-102 (also known as Lonsurf) is generally safe for patients with colorectal cancer. One study found that this combination allowed patients to live without their cancer worsening for about 6.33 months and live overall for about 18.4 months. This suggests the treatment can extend life with manageable side effects.

Fruquintinib alone has also demonstrated safety, with predictable and controllable side effects, especially in patients who have already tried other treatments for colorectal cancer. This is a positive indication of its safety.

Overall, both treatments have shown good safety results in studies, which is encouraging for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Fruquintinib combined with Lonsurf for colorectal cancer because this combo offers a fresh approach. Fruquintinib is a targeted therapy that blocks VEGFR, a protein that helps tumors grow new blood vessels, potentially slowing cancer growth. Lonsurf, a chemotherapy, brings a different angle by incorporating a unique combination of trifluridine and tipiracil, further disrupting cancer cell replication. This dual-action strategy aims to enhance treatment effectiveness compared to standard chemotherapy options like FOLFOX or FOLFIRI, offering hope for better patient outcomes.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research shows that combining Fruquintinib and Lonsurf (also known as TAS-102) may help treat metastatic colorectal cancer. Earlier studies found that this combination prevented cancer from worsening for about 6.33 months on average. Patients lived for an average of 18.4 months after starting treatment, even if they had tried other treatments before. In this trial, one arm will receive the combination of Fruquintinib and Lonsurf, while another arm will receive Fruquintinib alone. This suggests that using both drugs together might work better than using Fruquintinib alone. The evidence indicates that this combination could be a strong option for patients with advanced colorectal cancer that hasn't responded to other treatments. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or metastatic colorectal cancer that's microsatellite stable. They should have tried other treatments like fluoropyrimidine, oxaliplatin, and irinotecan without success or tolerated them poorly. Their cancer must not have improved after these treatments, and they need to be in good enough health to do normal activities with little help (ECOG ≤1).

Inclusion Criteria

I am willing and able to sign the consent form.

I am at least 18 years old.

I can follow the study's requirements and be available for its entire duration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fruquintinib and TAS-102 or Fruquintinib alone for refractory advanced/metastatic colorectal cancer

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fruquintinib
• TAS-102

Trial Overview

The study compares two approaches: one group receives Fruquintinib combined with TAS-102 (Lonsurf), while the other gets only Fruquintinib. It aims to see which treatment is better for patients whose colorectal cancer hasn't responded to standard therapies.

How Is the Trial Designed?

Group I: Fruquintinib and Lonsurf Experimental Treatment 1 Intervention

Group II: Fruquintinib Active Control 1 Intervention

Who Is Running the Clinical Trial?

Criterium, Inc.

Lead Sponsor

Trials

18

Recruited

730+

Citations

1.

onclive.com

onclive.com/view/fruquintinib-plus-tas-102-demonstrates-efficacy-and-acceptable-toxicity-in-pretreated-mcrc

Fruquintinib Plus TAS-102 Demonstrates Efficacy and ...

Fruquintinib and trifluridine/tipiracil combination achieved a median PFS of 6.33 months and OS of 18.4 months in mCRC patients after two prior ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06992258

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 ...

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/​Metastatic Colorectal Cancer (FRUITION).

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12432909/

New dosing schedules in pre-treated patients with ...

Zhang et al. presented clinical experience with an alternative dosing schedule of fruquintinib in patients with metastatic colorectal cancer ( ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2059702925001656

Quality-adjusted survival in patients with metastatic ...

The global, phase III FRESCO-2 study (NCT04322539) investigated the efficacy and safety of fruquintinib combined with best supportive care (BSC) in a patient ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10233702/

Evaluation of a Novel Combination Therapy, Based on ...

In both models, FTD/TPI and fruquintinib significantly inhibited tumor growth, and the activity of the combined treatment was significantly superior to that of ...

6.

academic.oup.com

academic.oup.com/oncolo/article/30/3/oyae360/8101338

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 ...