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NCT04488003 · ClinicalTrials.gov registry record · Phase 2

Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations

A Phase 2 study, sponsored by BioMed Valley Discoveries.

Terminated
Registry status
Phase 2
Development phase
104
Enrollment target

NCT04488003: Clinical Trial Phase 2 study, sponsored by BioMed Valley Discoveries.

NCT04488003 is a Phase 2 study that was terminated before completion, run by BioMed Valley Discoveries. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04488003, a Phase 2 study, was terminated before completion, sponsored by BioMed Valley Discoveries.

TERMINATED
Registry status
Phase 2
Development phase
104 participants
Enrollment target

Study Summary

This BVD-523-ABC study builds on the safety and clinical activity experience of previous studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of patients with specific genetic alterations and tumor histologies that result in aberrant MAPK pathway signaling. Early clinical data have demonstrated anti-tumor activity with ulixertinib treatment and have identified specific groups of patients for whom additional development is warranted.

Primary Outcome

ORR will be defined as the percentage of patients achieving a Best Overall Response (BOR) of confirmed Complete Response (CR) and/or Partial Response (PR). Patients will be evaluated at baseline \& at periodic follow-up visits through the time their participation in the study is complete.The best responses will occur at different time points for each patient.

Interventions

  • DRUG Ulixertinib
  • DRUG Physician's Choice

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2021-01-07
Est. Completion 2023-05-23
Phase Phase 2
BioMed Valley Discoveries

9 total trials

Why NCT04488003 stopped before completion

NCT04488003 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).

The record links to 0 conditions, and to 2 interventions - of which Ulixertinib is the first listed.

NCT04488003 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04488003 about?

NCT04488003 is a clinical study titled "Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations". This BVD-523-ABC study builds on the safety and clinical activity experience of previous studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of patients with specific genetic alterations and tumor histologies that result in aberrant MAPK pathway signaling. Early c...

What is the current status of trial NCT04488003?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2021-01-07. Estimated completion is 2023-05-23.

What interventions are being tested in trial NCT04488003?

The interventions under investigation include: Ulixertinib (DRUG), Physician's Choice (DRUG).

Who is sponsoring clinical trial NCT04488003?

This trial is sponsored by BioMed Valley Discoveries, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04488003's enrollment target sits among peer trials

104 660th of 2000 higher than 1,337 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 NCT04488003, the US trial registry maintained by the National Library of Medicine. NCT04488003 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.