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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: Recruiting Phase 2 study of Metastatic Colorectal Cancer (CRC), sponsored by The Methodist Hospital Research Institute.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

To assess the time to progression (TTP) of patients with locally advanced unresectable or metastatic colorectal cancer (mCRC) treated with 5-Fluorouracil (5FU)-based therapy in combination with fruquintinib, according to RECIST v1.1 criteria.

Conditions Studied

Metastatic Colorectal Cancer (CRC)

Interventions

  • DRUG Fruquintinib Combined With Chemotherapy

Study Locations (1)

Texas

  • Houston Methodist Neal Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2026-02
Est. Completion 2029-12
Phase Phase 2
The Methodist Hospital Research Institute

126 total trials

What NCT07042685 shows while recruiting

NCT07042685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 217-participant average among 5 other Metastatic Colorectal Cancer (CRC) trials with a reported enrollment target (77% lower).

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 a single indexed study location in 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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More recruiting context for NCT07042685

Source: ClinicalTrials.gov NCT07042685, the US trial registry maintained by the National Library of Medicine. NCT07042685 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.