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NCT03099486 · ClinicalTrials.gov registry record · Phase 2

Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC

A Phase 2 study, sponsored by Fox Chase Cancer Center.

Terminated
Registry status
Phase 2
Development phase
2
Enrollment target

NCT03099486: Clinical Trial Phase 2 study, sponsored by Fox Chase Cancer Center.

NCT03099486 is a Phase 2 study that was terminated before completion, run by Fox Chase Cancer Center. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03099486, a Phase 2 study, was terminated before completion, sponsored by Fox Chase Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
2 participants
Enrollment target

Study Summary

This is a single arm open label pilot phase II trial of Regorafenib PO plus 5-FU/LV infusion in 15 mCRC patients who progressed on prior Regorafenib monotherapy as well as 5-FU containing chemotherapy combinations.The study will enroll mCRC patients with prior progression on standard multi-agent combination chemotherapy and progression on regorafenib monotherapy.

Primary Outcome

PFS at 2 months in mCRC patients who progress on regorafenib monotherapy and are treated with regorafenib and 5-FU/LV combination therapy.

Interventions

  • DRUG Leucovorin
  • DRUG Regorafenib
  • DRUG 5-FU

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2017-10-06
Est. Completion 2020-06-02
Phase Phase 2
Fox Chase Cancer Center

183 total trials

Why NCT03099486 stopped before completion

NCT03099486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 3 interventions - of which Leucovorin is the first listed.

NCT03099486 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03099486 about?

NCT03099486 is a clinical study titled "Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC". This is a single arm open label pilot phase II trial of Regorafenib PO plus 5-FU/LV infusion in 15 mCRC patients who progressed on prior Regorafenib monotherapy as well as 5-FU containing chemotherapy combinations.The study will enroll mCRC patients with prior progression on standard multi-agent com...

What is the current status of trial NCT03099486?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2017-10-06. Estimated completion is 2020-06-02.

What interventions are being tested in trial NCT03099486?

The interventions under investigation include: Leucovorin (DRUG), Regorafenib (DRUG), 5-FU (DRUG).

Who is sponsoring clinical trial NCT03099486?

This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03099486's enrollment target sits among peer trials

2 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03099486, the US trial registry maintained by the National Library of Medicine. NCT03099486 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.