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Protein Kinase Inhibitor

Nilotinib + Dabrafenib/Trametinib for Melanoma

Phase 1
Recruiting
Led By Peng Wang, MD
Research Sponsored by Peng Wang, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new combination therapy for metastatic or unresectable melanoma that has 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.

Who is the study for?
Adults with metastatic or unresectable melanoma and a BRAF V600 mutation who have not responded to previous BRAFi/MEKi therapy can join. They must be HIV, HBV, and HCV undetectable if applicable, have treated brain metastases without progression, good organ function, no severe heart issues, and agree to use contraception.Check my eligibility
What is being tested?
This phase 1 trial tests different doses of Nilotinib combined with fixed-dose Dabrafenib and Trametinib in patients whose melanoma has spread. It aims to find the safest dose that's also effective while checking how these drugs affect each other in the body.See study design
What are the potential side effects?
Possible side effects include nausea, rash, fatigue, liver toxicity, changes in heartbeat rhythm (QT prolongation), high blood pressure (hypertension), bleeding problems (hemorrhage), vision changes like blurred vision or reduced sharpness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Patients Experiencing Dose Limiting Toxicities
Secondary outcome measures
Change in Nilotinib Concentration
Dose-Adjusted Steady State Concentration of Dabrafenib
Duration of Response

Trial Design

4Treatment groups
Experimental Treatment
Group I: Level 4Experimental Treatment3 Interventions
Patients in this group will receive 400mg Nilotinib PO BID.
Group II: Level 3Experimental Treatment3 Interventions
Patients in this group will receive 300mg Nilotinib PO BID.
Group III: Level 2Experimental Treatment3 Interventions
Patients in this group will receive 200mg Nilotinib PO BID.
Group IV: Level 1Experimental Treatment3 Interventions
Patients in this group will receive 100mg Nilotinib PO BID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~4120
Trametinib
2014
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

Peng Wang, MD PhDLead Sponsor
3 Previous Clinical Trials
48 Total Patients Enrolled
Jill M KolesarLead Sponsor
3 Previous Clinical Trials
518 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,020 Total Patients Enrolled
19 Trials studying Melanoma
3,857 Patients Enrolled for Melanoma

Media Library

Dabrafenib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04903119 — Phase 1
Melanoma Research Study Groups: Level 1, Level 2, Level 3, Level 4
Melanoma Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT04903119 — Phase 1
Dabrafenib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903119 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Trametinib been explored in any prior research?

"Currently, 11 Trametinib trials are in their 3rd phase. While Ulm and Fukuoka have significant Trametinib research happening, over 7299 clinical trial sites across the world are running studies for this medication."

Answered by AI

Is there availability in this clinical study for new participants?

"Affirmative, clinicaltrials.gov indicates that this research project is now searching for participants. The study was first uploaded on June 1st 2022 and has since been amended up to September 9th 2022. 15 individuals across a single medical site are required for enrollment in the trial."

Answered by AI

What degree of security can patients anticipate when taking Trametinib?

"Trametinib's safety is classified as a 1 due to the limited evidence collected from Phase 1 trials, which only provide data for efficacy and risk."

Answered by AI

What conditions is Trametinib prescribed to address?

"Trametinib is regularly prescribed to treat melanoma that cannot be excised surgically. It has also proven successful in managing myeloid leukemia, gastrointestinal stromal tumors and different phases of chronic myeloid leukemia."

Answered by AI

Is this an innovative research endeavor?

"Presently, there are 127 active trials on Trametinib in 1271 cities and 46 nations. The inaugural trial of this drug was conducted back in 2008 by Novartis Pharmaceuticals with a sample size of 34 individuals. Following the Phase 4 approval stage, 164 further studies have been performed as of today."

Answered by AI

What is the participant size of this medical experiment?

"Affirmative. According to information posted on clinicaltrials.gov, this medical trial is presently recruiting patients and was first published June 1st 2022 with the last update occurring September 9th of the same year. The study seeks 15 individuals from a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma
Jill M Kolesar 2022. "Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04903119.
~9 spots leftby Dec 2026
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