Fruquintinib + FOLFIRI for Colorectal Cancer

(FRUITFUL Trial)

Recruiting at 10 trial locations

Overseen By Sarah Cannon Sarah Cannon Development Innovations, LLC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SCRI Development Innovations, LLC

Must be taking: FOLFOX, Bevacizumab

Must not be taking: Anticancer treatments

Disqualifiers: Uncontrolled hypertension, Brain metastases, Pregnancy, 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: 2

Duration: Up to 2 years

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination treatment for individuals with metastatic colorectal cancer (mCRC), which is colon or rectal cancer that has spread. Researchers aim to assess the effectiveness and safety of pairing the drug fruquintinib, a targeted therapy, with a chemotherapy regimen called FOLFIRI. The trial seeks participants who have already tried a specific first-line treatment for mCRC but require a second option. Interested individuals should have a confirmed diagnosis of mCRC and have previously received FOLFOX with Bevacizumab. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any other anticancer treatments at least 21 days before starting the study treatment. It doesn't specify about other medications, so you should discuss your current medications with the trial team.

Is there any evidence suggesting that the combination of fruquintinib and FOLFIRI is likely to be safe for humans?

Research has shown that the combination of fruquintinib and FOLFIRI is generally well-tolerated by patients with advanced colorectal cancer. In one study, 25% of patients experienced diarrhea, but only 4% had severe cases, indicating that most managed the treatment without serious issues. Fruquintinib fights cancer by blocking the blood vessels that supply tumors. A review of studies in China found that fruquintinib improved both overall survival and the time patients lived without the cancer worsening, without adding more side effects. These findings suggest the treatment is relatively safe, but ongoing trials will provide more information. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for colorectal cancer?

Researchers are excited about the combination of Fruquintinib with FOLFIRI for colorectal cancer because Fruquintinib offers a novel mechanism of action. Unlike standard treatments like chemotherapy that broadly attack cancer cells, Fruquintinib specifically targets and inhibits vascular endothelial growth factor receptors (VEGFR), which are crucial for tumor blood supply. This approach can potentially enhance the effectiveness of FOLFIRI by starving the tumor of nutrients and oxygen, making it a promising addition to current treatment strategies.

What evidence suggests that the combination of fruquintinib and FOLFIRI could be an effective treatment for metastatic colorectal cancer?

Research has shown promising results for using fruquintinib combined with FOLFIRI to treat metastatic colorectal cancer (mCRC). One study revealed that patients with RAS-mutant mCRC, who received this combination as a second treatment option, experienced significant benefits. Another study found that 77% of patients responded positively, indicating a high percentage saw improvements. These findings suggest that the combination of fruquintinib and FOLFIRI, which participants in this trial will receive, could be an effective treatment option for mCRC patients. ^{1 2 4 5 6}

Who Is on the Research Team?

Meredith Pelster, MD

Principal Investigator

SCRI Oncology Partners

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic colorectal cancer who have already undergone one line of therapy. Participants should be able to receive the FOLFIRI regimen and must not have conditions that exclude them from the study as per specific criteria not listed here.

Inclusion Criteria

I have been treated with FOLFOX and Bevacizumab for colorectal cancer.

I can perform daily activities with little to no assistance.

I am at least 18 years old.

Exclusion Criteria

Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy

I have brain metastases that are not under control and cause symptoms.

Documented major electrocardiogram (ECG) abnormalities which are clinically significant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fruquintinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion every 2 weeks. Each cycle is 28 days.

Up to 2 years

Every 2 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FOLFIRI
• Fruquintinib

Trial Overview The study tests how well fruquintinib combined with FOLFIRI works as a second-line treatment for mCRC. It's an open-label, multicenter Phase II trial aiming to assess both the effectiveness and safety of this combination therapy.

How Is the Trial Designed?

Group I: Fruquinitinib + FOLFIRI Experimental Treatment 2 Interventions

Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled.

Who Is Running the Clinical Trial?

SCRI Development Innovations, LLC

Lead Sponsor

Trials

193

Recruited

13,800+

Takeda Development Center Americas, Inc.

Industry Sponsor

Trials

58

Recruited

10,800+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.151

Fruquintinib combined with FOLFIRI/mFOLFOX6 as second ... Conclusions: Fruquintinib combined with FOLFIRI/mFOLFOX6 as second-line in patients with RAS-mutant mCRC achieved a promising clinical benefit, ...

2. asco.org asco.org/abstracts-presentations/ABSTRACT393544

Efficacy and safety of fruquintinib plus mFOLFOX6/FOLFIRI ... 54% treated with mFOLFOX6. At a median follow-up of 5.9mo, all 13 pts are still on treatment. In best overall response assessment, the ORR is 77%, with 10 (77%) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07011576

NCT07011576 | A Study of Fruquintinib Plus FOLFIRI as ... This study is an open-label Phase II study designed to evaluate the efficacy and safety of fruquintinib + FOLFIRI in 2nd-line setting mCRC participants who have ...

4. 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%, ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e15541

Preliminary results of fruquintinib in combination with ... Diarrhea occurred in 25% of patients, with 4% being grade 3. Conclusions: The study is ongoing. These preliminary results demonstrate that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454978/

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