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sitravatinib for Liver Disease
Study Summary
This trial looks at how different levels of liver damage affect the body's ability to process sitravatinib, a drug used to treat cancer.
- Liver Disease
Timeline
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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
Is recruitment still open for this medical research?
"At this juncture, the study is not actively recruiting. Initially posted on March 12th 2021 and last edited November 17th 2022 , it has been on clinicaltrials.gov for over a year; however, those seeking alternative research opportunities can find 258 trials that are accepting patients with liver diseases and 16 studies involving sitravatinib."
Has there been any additional research conducted around the efficacy of sitravatinib?
"Presently, 16 trials involving sitravatinib are taking place. 3 of those investigations have reached their third phase. Data shows that the majority of studies occur in New Haven, Connecticut although there are 443 research sites worldwide running related experiments."
How has the risk profile of sitravatinib been assessed?
"The safety of sitravatinib is still in the early stages and was therefore assigned a score of 1. As this medicine is going through Phase 1 trials, there are minimal data points supporting its efficacy or safety."
Is the age criterion for participation in this research study limited to adults?
"This experiment is enrolling patients between 18 and 75 years old."
How many volunteers have enrolled in this research program?
"This trial has closed its recruitment period. First launched on 3/12/2021, it was last updated on 11/17/2022. If you are interested in alternative studies, the database presently includes 258 trials for liver diseases and 16 trials using sitravatinib that have open enrolment slots."
What criteria must potential participants meet to be eligible for this trial?
"This clinical trial is seeking 30 individuals, aged 18 to 75 years old with liver ailments. To be considered for the study they must be able to comprehend and agree to sign an Informed Consent Form (ICF) as well as abide by all of its regulations. Additionally, each participant's Child Pugh Score will need to calculated at screening in order to receive a mild, moderate or severe hepatic impairment classification; these scores shall also be recalculated during check-in for safety purposes. Eligible persons should have a BMI between 18 and 40 kg/m2 and come from any race or gender identity."
How many healthcare facilities are currently involved in this experiment?
"At present, there are 5 sites participating in this trial; Orlando, Austin, and Miami being the most prominent. For those interested in enrolling, it is advised to look for a clinic located nearby to reduce travel time."
Has this research been conducted previously, or is it a new initiative?
"Currently, innovative research on sitravatinib is underway at 16 different trial sites across 14 nations. Initially starting in 2015 with the sponsorship of Mirati Therapeutics Inc., this study has seen 423 participants progress through its Phase 2 drug approval stage. Following that initial undertaking, a further 6 trials have been completed since then."
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