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Tyrosine Kinase Inhibitor

Sitravatinib for Healthy Adults

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours after dosing
Awards & highlights

Study Summary

This study is evaluating whether a drug that reduces stomach acid can affect the absorption of a drug that is used to treat cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours after dosing 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 - Cmax (sitravatinib)
Secondary outcome measures
Adverse Events (AEs)

Side effects data

From 2023 Phase 2 trial • 25 Patients • NCT03680521
86%
Hypertension
71%
Dysphonia
57%
Headache
43%
Fatigue
43%
Constipation
43%
Lipase increased
43%
Oral dysaesthesia
29%
Blood thyroid stimulating hormone increased
29%
Hypothyroidism
29%
Hypotension
29%
Myalgia
29%
Diarrhoea
29%
Urinary tract infection
29%
Vomiting
29%
Pain
29%
Amylase increased
14%
Arthralgia
14%
Cough
14%
Abdominal pain
14%
Acute respiratory failure
14%
Weight decreased
14%
Nasal congestion
14%
Epistaxis
14%
Flank pain
14%
Alanine aminotransferase increased
14%
Hyperuricaemia
14%
Memory impairment
14%
Musculoskeletal pain
14%
Night sweats
14%
Urinary retention
14%
Nausea
14%
Rash
14%
Decreased appetite
14%
Dizziness
14%
Haematuria
14%
Nail discolouration
14%
Hypoglycaemia
14%
Oral herpes
14%
Pain in jaw
14%
Pneumonitis
14%
Procedural pain
14%
Pyrexia
14%
Rhinitis allergic
14%
Rhinorrhoea
14%
Sinus congestion
14%
Somnolence
14%
Thrombocytopenia
14%
Tinnitus
14%
Tooth abscess
14%
Herpes zoster
14%
Chills
14%
Urosepsis
14%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sitravatinib 120 mg
Sitravatinib 80 mg

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 2 Treatment D (sitravatinib and famotidine)Experimental Treatment2 Interventions
Period 2: A single oral dose of 100 mg sitravatinib followed by a single oral dose of famotidine 40 mg approximately 2 hours after sitravatinib dose on Day 1
Group II: Group 2 Treatment C (sitravatinib only)Experimental Treatment1 Intervention
Period 1: A single oral dose of 100 mg sitravatinib on Day 1
Group III: Group 1 Treatment B (sitravatinib and pantoprazole)Experimental Treatment2 Interventions
Period 2: Oral pantoprazole once daily for 7 days (Days 1 to 7) and a single oral dose of 100 mg sitravatinib on Day 7
Group IV: Group 1 Treatment A (sitravatinib only)Experimental Treatment1 Intervention
Period 1: A single oral dose of 100 mg sitravatinib on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitravatinib
2021
Completed Phase 2
~490
Pantoprazole
2014
Completed Phase 4
~1500
Famotidine
2005
Completed Phase 4
~1700

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
8,190 Total Patients Enrolled
4 Trials studying Healthy Adults
106 Patients Enrolled for Healthy Adults
Curtis Chin, MDStudy DirectorMirati Therapeutics Inc.
4 Previous Clinical Trials
198 Total Patients Enrolled
1 Trials studying Healthy Adults
36 Patients Enrolled for Healthy Adults

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Explore the Effect of Acid-reducing Agents
2021. "A Study to Explore the Effect of Acid-reducing Agents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04935112.
~4 spots leftby Apr 2025
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