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A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)

RecruitingPhase 2Ages 18 Years - anyAllSCRI Development Innovations, LLC
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion 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 line of therapy must have been completed. * 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 Exclusion Criteria: * 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
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What it tests

  • fruquintinib
  • FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
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Where

14 sites
Rocky Mountain Cancer Center - Primary
Denver, United States
Illinois Cancer Specialists
Arlington Heights, United States
Maryland Oncology Hematology
Columbia, United States
Minnesota Oncology Hematology - Primary
Maple Grove, United States
Missouri Cancer Associates
Columbia, United States
Oncology Associates of Oregon - Primary
Eugene, United States
Northwest Cancer Specialists - Compass
Portland, United States
Alliance Cancer Specialists
Wynnewood, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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