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RECRUITING Phase 2

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

NCT07011576 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

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

Study Locations (14)

Texas

  • Texas Oncology - Central/South Texas — Austin
  • Texas Oncology - Gulf Coast — Beaumont
  • Texas Oncology - Northeast Texas — Tyler

Oregon

  • Oncology Associates of Oregon - Primary — Eugene
  • Northwest Cancer Specialists - Compass — Portland

Virginia

  • Virginia Oncology Associates — Norfolk
  • Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA) — Salem

Colorado

  • Rocky Mountain Cancer Center - Primary — Denver

Illinois

  • Illinois Cancer Specialists — Arlington Heights

Maryland

  • Maryland Oncology Hematology — Columbia

Minnesota

  • Minnesota Oncology Hematology - Primary — Maple Grove

Missouri

  • Missouri Cancer Associates — Columbia

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-09-29
Est. Completion 2027-06
Phase Phase 2

Sponsor

SCRI Development Innovations

63 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07011576

The ClinicalTrials.gov registry entry for NCT07011576 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 63 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which fruquintinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07011576 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Texas, Oregon, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07011576 about?

NCT07011576 is a clinical study titled "A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)". 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 co...

What is the current status of trial NCT07011576?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-09-29. Estimated completion is 2027-06.

What conditions does trial NCT07011576 study?

This clinical trial studies the following conditions: Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Cancer (CRC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07011576?

The interventions under investigation include: fruquintinib (DRUG), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07011576?

This trial is sponsored by SCRI Development Innovations, which has 63 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07011576 being conducted?

This trial has 14 study locations across Colorado, Illinois, Maryland, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial