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New treatment option for Colon Cancer
Official title A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
ClinicalTrials.gov ID: NCT07011576
What this study is testing
What is fruquintinib?
fruquintinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for colon cancer.
Also referred to as Fruzaqla.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to: Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting Evaluate the safety of the combination of fruquintinib + FOLFIRI
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
- Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
- Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and...
- At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 Key
You likely can't join if
- Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
- Major surgery within 4 weeks of the first planned dose of study treatment
- More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
- Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and...
- Uncontrolled, symptomatic brain metastases
- Uncontrolled, symptomatic gastrointestinal disease
See the full eligibility criteria
- Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
- Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
- Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first...
- At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 Key
- Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
- Major surgery within 4 weeks of the first planned dose of study treatment
- More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
- Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
- Uncontrolled, symptomatic brain metastases
- Uncontrolled, symptomatic gastrointestinal disease
- Participants with uncontrolled hypertension
- 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
- Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
- Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
- Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
- Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Arlington Heights, Illinois, United States
- Columbia, Maryland, United States
- Maple Grove, Minnesota, United States
- Columbia, Missouri, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
- Wynnewood, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Beaumont, Texas, United States
- Tyler, Texas, United States
- Norfolk, Virginia, United States
- Salem, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Arlington Heights, Illinois, United States; Columbia, Maryland, United States; Maple Grove, Minnesota, United States; Columbia, Missouri, United States; Eugene, Oregon, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.