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Tyrosine Kinase Inhibitor

sitravatinib for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Mirati Therapeutics Inc.
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 days 1 - 4
Awards & highlights

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.

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 - 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 - 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics - AUClast (sitravatinib)
Pharmacokinetics - AUC∞ (sitravatinib)
Pharmacokinetics - CL/F (sitravatinib)
+5 more
Secondary outcome measures
Adverse Events (AEs)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Sitravatinib in subjects with severe hepatic impairmentExperimental Treatment1 Intervention
Participants will receive a single dose of sitravatinib 100 mg receive on Day 1 in subjects with severe hepatic impairment
Group II: Sitravatinib in subjects with moderate hepatic impairmentExperimental Treatment1 Intervention
Participants will receive a single dose of sitravatinib 100 mg receive on Day 1 in subjects with moderate hepatic impairment
Group III: Sitravatinib in subjects with mild hepatic impairmentExperimental Treatment1 Intervention
Participants will receive a single dose of sitravatinib 100 mg receive on Day 1 in subjects with mild hepatic impairment
Group IV: Sitravatinib in healthy subjectsExperimental Treatment1 Intervention
Participants will receive a single dose of sitravatinib 100 mg receive on Day 1 in healthy subjects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sitravatinib
2021
Completed Phase 1
~70

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
8,225 Total Patients Enrolled
Curtis Chin, MDStudy DirectorMirati Therapeutics
4 Previous Clinical Trials
183 Total Patients Enrolled

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Is the age criterion for participation in this research study limited to adults?

"This experiment is enrolling patients between 18 and 75 years old."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~7 spots leftby Apr 2025