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NCT07042685 · ClinicalTrials.gov registry record · Phase 2
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
A Phase 2 study of Metastatic Colorectal Cancer (CRC), sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT07042685 is a Phase 2 study of Metastatic Colorectal Cancer (CRC) that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 50 participants, below the 217-participant average among 5 other Metastatic Colorectal Cancer (CRC) trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07042685, a Phase 2 study of Metastatic Colorectal Cancer (CRC), is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase II clinical trial at Houston Methodist Neal Cancer Center is evaluating the safety and efficacy of combining 5-Fluorouracil (5FU) -based chemotherapy (either FOLFIRI: folinic acid, 5FU, irinotecan; or mFOLFOX6: folinic acid, 5FU, oxaliplatin) with fruquintinib as a first-line treatment for patients with locally advanced unresectable or metastatic colorectal cancer. Fifty patients will receive treatment in 28-day cycles, with fruquintinib initially dosed at 4 mg daily and potentially increased to 5 mg if no significant toxicities are observed. After six months, patients showing stable disease or better will transition to a maintenance phase with 5FU and fruquintinib, continuing until disease progression or other discontinuation criteria are met. The primary endpoint is time to progression based on RECIST v1.1 criteria, while secondary endpoints include safety, tolerability, and duration of response. The trial is being conducted across multiple Houston Methodist hospitals and is currently the only first-line CRC trial available in the system. If successful, it could offer a new therapeutic option and inform future treatment guidelines for advanced colorectal cancer.
Conditions Studied
Interventions
- DRUG Fruquintinib Combined With Chemotherapy
Study Locations (1)
Texas
- Houston Methodist Neal Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-02 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07042685
The ClinicalTrials.gov registry entry for NCT07042685 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 217-participant average among 5 other Metastatic Colorectal Cancer (CRC) trials with a reported enrollment target (77% lower). The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Colorectal Cancer (CRC) appearing as the primary indexed condition, and to 1 intervention - of which Fruquintinib Combined With Chemotherapy is the first listed.
NCT07042685 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT07042685 about?
NCT07042685 is a clinical study titled "Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer". This Phase II clinical trial at Houston Methodist Neal Cancer Center is evaluating the safety and efficacy of combining 5-Fluorouracil (5FU) -based chemotherapy (either FOLFIRI: folinic acid, 5FU, irinotecan; or mFOLFOX6: folinic acid, 5FU, oxaliplatin) with fruquintinib as a first-line treatment fo...
What is the current status of trial NCT07042685?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-02. Estimated completion is 2029-12.
What conditions does trial NCT07042685 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer (CRC).
What interventions are being tested in trial NCT07042685?
The interventions under investigation include: Fruquintinib Combined With Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT07042685?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07042685 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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