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NCT04903119 · ClinicalTrials.gov registry record · Phase 1
Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
A Phase 1 study of Metastatic Melanoma and BRAF Gene Mutation, sponsored by Rina Plattner.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT04903119: Recruiting Phase 1 study of Metastatic Melanoma and BRAF Gene Mutation, sponsored by Rina Plattner.
NCT04903119 is a Phase 1 study of Metastatic Melanoma and BRAF Gene Mutation that is actively recruiting participants, run by Rina Plattner. The registered enrollment target is 30 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (64% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04903119, a Phase 1 study of Metastatic Melanoma and BRAF Gene Mutation, is actively recruiting participants, sponsored by Rina Plattner.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal is to assess the toxicity and tolerability and determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the combination of nilotinib with dabrafenib and trametinib or with encorafenib and binimetinib. Additionally, this study will assess pharmacokinetic parameters of dabrafenib and nilotinib when used in combination.
Primary Outcome
Percentage of patients who experienced dose-limiting toxicities associated with Nilotinib as defined by the study protocol.
Conditions Studied
Interventions
- DRUG Dabrafenib
- DRUG Nilotinib 100mg
- DRUG Nilotinib 200mg
- DRUG Nilotinib 300mg
- DRUG Nilotinib 400mg
Study Locations (4)
Iowa
- University of Iowa - Iowa City
Kentucky
- Markey Cancer Center - Lexington
Pennsylvania
- St. Luke's University Health Network - Easton
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2030-06-01 |
| Phase | Phase 1 |
What NCT04903119 shows while recruiting
NCT04903119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Dabrafenib is the first listed.
NCT04903119 reports a single indexed study location in Iowa, Kentucky, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04903119 about?
NCT04903119 is a clinical study titled "Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma". This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal is to assess the toxicity and tolerabi...
What is the current status of trial NCT04903119?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-06-01. Estimated completion is 2030-06-01.
What conditions does trial NCT04903119 study?
This clinical trial studies the following conditions: Metastatic Melanoma, BRAF Gene Mutation.
What interventions are being tested in trial NCT04903119?
The interventions under investigation include: Dabrafenib (DRUG), Nilotinib 100mg (DRUG), Nilotinib 200mg (DRUG), Nilotinib 300mg (DRUG), Nilotinib 400mg (DRUG).
Who is sponsoring clinical trial NCT04903119?
This trial is sponsored by Rina Plattner, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04903119 being conducted?
This trial has 4 study locations across Iowa, Kentucky, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04903119's enrollment target sits among peer trials
30 55th of 91 higher than 33 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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.
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