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NCT05868629 · ClinicalTrials.gov registry record
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
A clinical trial of Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- 40
- Enrollment target
- 7
- Study locations
NCT05868629: Recruiting study of Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors, sponsored by Novartis Pharmaceuticals.
NCT05868629 is a study of Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 40 participants. The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05868629, a study of Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.
Primary Outcome
Proportion of study participants with a best overall confirmed Complete Response (CR) or Partial Response (PR) by independent central review according to RECIST v1.1 or other relevant response criteria.
Conditions Studied
Interventions
- OTHER Non-investigational
Study Locations (7)
Texas
- El Paso Texas Oncology - El Paso
- Texas Oncology San Antonio - San Antonio
California
- Lundquist Inst BioMed at Harbor - Torrance
District of Columbia
- Johns Hopkins University - Washington D.C.
North Carolina
- Duke Clinical Research Institute - Durham
Ohio
- Oncology Hematology Care Inc - Cincinnati
Tennessee
- Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-02-06 |
| Est. Completion | 2028-03-03 |
What NCT05868629 shows while recruiting
NCT05868629 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 1 condition, with Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Non-investigational is the first listed.
NCT05868629 lists 7 locations in 6 states (Texas, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05868629 about?
NCT05868629 is a clinical study titled "Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors". This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trameti...
What is the current status of trial NCT05868629?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2024-02-06. Estimated completion is 2028-03-03.
What conditions does trial NCT05868629 study?
This clinical trial studies the following conditions: Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors.
What interventions are being tested in trial NCT05868629?
The interventions under investigation include: Non-investigational (OTHER).
Who is sponsoring clinical trial NCT05868629?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05868629 being conducted?
This trial has 7 study locations across California, District of Columbia, North Carolina, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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