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NCT07011576 · ClinicalTrials.gov registry record · Phase 2
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
A Phase 2 study of Colorectal Cancer and Colon Cancer, sponsored by SCRI Development Innovations.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 14
- Study locations
NCT07011576: Recruiting Phase 2 study of Colorectal Cancer and Colon Cancer, sponsored by SCRI Development Innovations.
NCT07011576 is a Phase 2 study of Colorectal Cancer and Colon Cancer that is actively recruiting participants, run by SCRI Development Innovations. The registered enrollment target is 60 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (96% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07011576, a Phase 2 study of Colorectal Cancer and Colon Cancer, is actively recruiting participants, sponsored by SCRI Development Innovations.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 14
- Study locations
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
Primary Outcome
Progression-Free Survival (PFS) rate at 6 months, defined as the percentage of participants at 6 months who have not experienced disease progression as defined by the RECIST Version 1.1 criteria or death on study. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-09-29 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What NCT07011576 shows while recruiting
NCT07011576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (96% lower).
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.
NCT07011576 lists 14 locations in 10 states (Texas, Oregon, Virginia).
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).
What interventions are being tested in trial NCT07011576?
The interventions under investigation include: fruquintinib (DRUG), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) (DRUG).
Who is sponsoring clinical trial NCT07011576?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07011576's enrollment target sits among peer trials
60 258th of 381 higher than 121 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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