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Study Summary
This trial is testing the safety and efficacy of two or three drugs to treat patients with advanced solid tumors. The trial will enroll at least 18 patients for the dual combination and at least 12 patients for the triple combination.
- Solid Tumors with BRAF V600 Mutation
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
What diseases are typically targeted by LEE011?
"LEE011 is often prescribed to patients suffering from neoplasms, braf v600e mutation, metastatic melanoma, and unresectable melanoma."
What is the ultimate aim of this research endeavor?
"The primary objective of this 14-month clinical trial is to determine the Maximum Tolerated Dose (MTD) based on the incidence of dose limiting toxicities (DLT). Additionally, researchers will measure plasma concentrations for pharmacokinetics and evaluate preliminary anti-tumor activity through an objective response rate. Finally, safety and tolerability must be evaluated by assessing adverse events throughout the study period."
What other research projects have been conducted featuring LEE011?
"At present, there are 109 active clinical trials focusing on LEE011 with 11 of these in Phase 3. Camperdown, New South Wales is home to several of the LEE011 experiments and 4959 sites worldwide are taking part in its research."
What is the capacity of participants for this exploration?
"At this moment, the clinical trial is not enrolling patients. First posted on May 30th 2012 and last updated November 22nd 2022, it has since been discontinued. For those seeking other studies, there are 2374 solid tumors containing a BRAF V600 mutation trials actively recruiting participants as well as 109 LEE011 ones doing so too."
How many health care institutions are administering this experiment within the state?
"Patients with the relevant medical condition can be enrolled in this trial at MD Anderson Cancer Center (Houston, Texas), Ophthalmic Consultants of Boston Inc. (Montreal, Quebec) and Sir Mortimer B. Davis-Jewish General Hospital (Tampa, Florida) plus 8 other sites."
Is there any remaining capacity for participants in this research endeavor?
"This research has concluded its recruitment stage, having initially been posted on May 30th 2012 and lastly edited November 22nd 2022. For those still looking for trials to join, there are 2374 clinical studies actively enrolling patients with solid tumors harbouring a BRAF V600 mutation and 109 more specifically targeting LEE011."
Is this endeavor a pioneering trial?
"Research into LEE011 has been conducted since 2011, when Pfizer sponsored the first trial involving 183 participants. This study led to Phase 2 drug approval for this medication in the same year. Currently there are 109 active trials of LEE011 being held across 54 nations and 1507 cities."
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