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NCT04527549 · ClinicalTrials.gov registry record · Phase 2
Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma
A Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04527549: Clinical Trial Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
NCT04527549 is a Phase 2 study that was terminated before completion, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04527549, a Phase 2 study, was terminated before completion, sponsored by ECOG-ACRIN Cancer Research Group.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This phase II trial investigates how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma. Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.
Primary Outcome
Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demons
Interventions
- DRUG Placebo Administration
- DRUG Hydroxychloroquine
- DRUG Dabrafenib mesylate
- DRUG Trametinib dimethyl sulfoxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2024-01-08 |
| Phase | Phase 2 |
Why NCT04527549 stopped before completion
NCT04527549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Administration is the first listed.
NCT04527549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04527549 about?
NCT04527549 is a clinical study titled "Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma". This phase II trial investigates how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma. Hydroxychloroquine may cause cell death in tumor cel...
What is the current status of trial NCT04527549?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-06-01. Estimated completion is 2024-01-08.
What interventions are being tested in trial NCT04527549?
The interventions under investigation include: Placebo Administration (DRUG), Hydroxychloroquine (DRUG), Dabrafenib mesylate (DRUG), Trametinib dimethyl sulfoxide (DRUG).
Who is sponsoring clinical trial NCT04527549?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04527549's enrollment target sits among peer trials
5 2000th 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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