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NCT04985604 · ClinicalTrials.gov registry record · Phase 2

Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors

A Phase 2 study, sponsored by Day One Biopharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
23
Enrollment target

NCT04985604: Clinical Trial Phase 2 study, sponsored by Day One Biopharmaceuticals.

NCT04985604 is a Phase 2 study that was terminated before completion, run by Day One Biopharmaceuticals. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04985604, a Phase 2 study, was terminated before completion, sponsored by Day One Biopharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

This is a Phase 2, multi-center, open-label to evaluate the efficacy and safety of tovorafenib (DAY101) in participants ≥12 years of age with recurrent or progressive melanoma or solid tumors with BRAF fusion or CRAF/RAF1 fusions or amplification.

Primary Outcome

ORR was defined as the percentage of participants with the best overall confirmed response of complete response (CR) or partial response (PR) according to the appropriate response assessment criteria including Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for the disease setting as assessed by the Investigator. CR or PR was confirmed at a subsequent scan (\>=4 weeks) if the criteria for each are met . The exact 95% confidence intervals

Interventions

  • DRUG Tovorafenib

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2021-07-15
Est. Completion 2024-07-08
Phase Phase 2
Day One Biopharmaceuticals

5 total trials

Why NCT04985604 stopped before completion

NCT04985604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Tovorafenib is the first listed.

NCT04985604 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04985604 about?

NCT04985604 is a clinical study titled "Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors". This is a Phase 2, multi-center, open-label to evaluate the efficacy and safety of tovorafenib (DAY101) in participants ≥12 years of age with recurrent or progressive melanoma or solid tumors with BRAF fusion or CRAF/RAF1 fusions or amplification.

What is the current status of trial NCT04985604?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2021-07-15. Estimated completion is 2024-07-08.

What interventions are being tested in trial NCT04985604?

The interventions under investigation include: Tovorafenib (DRUG).

Who is sponsoring clinical trial NCT04985604?

This trial is sponsored by Day One Biopharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04985604's enrollment target sits among peer trials

23 1784th of 2000 higher than 211 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 NCT04985604, the US trial registry maintained by the National Library of Medicine. NCT04985604 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.