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Sitravatinib for Solid Tumors

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 part 1: pre-dose to day 10 (qtc cohort); part 1: pre-dose to day14 (ddi cohort)
Awards & highlights

Study Summary

This trial is studying how the drug sitravatinib affects other drugs and how it affects the heart.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: pre-dose to day 10 (qtc cohort); part 1: pre-dose to day14 (ddi cohort)
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: pre-dose to day 10 (qtc cohort); part 1: pre-dose to day14 (ddi cohort) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmaceutical Preparations
PK parameters of probe drugs; AUC from time zero to the last data point (AUC-last)
PK parameters of probe drugs; C-max
Secondary outcome measures
Adverse Events
Plasma PK parameters of sitravatinib and M10; AUC over the dosing interval (AUC)
Plasma PK parameters of sitravatinib and M10; C-max
+3 more

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%
Hypotension
29%
Hypothyroidism
29%
Blood thyroid stimulating hormone increased
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

3Treatment groups
Experimental Treatment
Group I: Phase 1, Part 2: Combination Therapy (both DDI and QTc cohorts)Experimental Treatment2 Interventions
To evaluate safety and tolerability of Sitravatinib treatment with the addition of the checkpoint inhibitor nivolumab.
Group II: Phase 1, Part 1: Sitravatinib monotherapy (QTc cohort)Experimental Treatment1 Intervention
To evaluate the QTc prolongation risk for sitravatinib in patients with advanced/metastatic solid tumors via C-QTc modeling.
Group III: Phase 1, Part 1: Sitravatinib monotherapy (DDI cohort)Experimental Treatment6 Interventions
To evaluate the potential for drug-drug interactions (DDI) with sitravatinib monotherapy. To determine the effect of sitravatinib on the pharmacokinetics (PK) of midazolam (CYP3A4 probe substrate), warfarin (CYP2C9 probe substrate), dextromethorphan (CYP2D6 probe substrate), rosuvastatin (BCRP probe substrate), and digoxin (P-gp probe substrate).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digoxin
2017
Completed Phase 4
~670
Rosuvastatin
2019
Completed Phase 4
~3150
Nivolumab
2014
Completed Phase 3
~4750
Sitravatinib
2021
Completed Phase 2
~700
Warfarin
2017
Completed Phase 4
~248220
Dextromethorphan
2019
Completed Phase 4
~920
Midazolam
2018
Completed Phase 4
~1910

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
8,215 Total Patients Enrolled
Curtis Chin, MDStudy DirectorMirati Therapeutics Inc.
4 Previous Clinical Trials
173 Total Patients Enrolled

Media Library

PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates Clinical Trial Eligibility Overview. Trial Name: NCT04887194 — Phase 1
Solid Tumors Research Study Groups: Phase 1, Part 1: Sitravatinib monotherapy (DDI cohort), Phase 1, Part 1: Sitravatinib monotherapy (QTc cohort), Phase 1, Part 2: Combination Therapy (both DDI and QTc cohorts)
Solid Tumors Clinical Trial 2023: PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates Highlights & Side Effects. Trial Name: NCT04887194 — Phase 1
PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates 2023 Treatment Timeline for Medical Study. Trial Name: NCT04887194 — Phase 1

Frequently Asked Questions

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

What past experiments have been conducted to explore the efficacy of Sitravatinib?

"Currently, 871 clinical trials are actively investigating the effects of Sitravatinib. Of these studies, 121 have reached Phase 3 with a wide variety of research sites from Porto Alegre to California. Altogether, 41949 locations across the world are engaged in researching this novel treatment option."

Answered by AI

What level of risk do patients experience when using Sitravatinib?

"Power Group assigned a rating of 1 to the safety profile of Sitravatinib, as this is an early-stage trial with limited evidence for efficacy and safety."

Answered by AI

What goals is this research endeavor attempting to achieve?

"In Part 1 of the trial, which will take place over a period of up to 20 days, primary outcomes include sitravatinib and M10's Area Under The Curve from time zero to infinity (AUC∞). Secondary measures comprise AUC over the dosing interval (AUC), time to maximum concentration (t-max) and C-max."

Answered by AI

Are there any vacancies available to potential participants in this trial?

"Clinicaltrials.gov confirms that this research project is no longer accepting participants, having been initially posted on March 26th 2021 and last edited on October 6th 2022. Nonetheless, there are 1341 other trials actively recruiting right now."

Answered by AI

What medical indications is Sitravatinib typically prescribed for?

"Sitravatinib is the gold standard for treating hypertriglyceridemias, but it can also help patients with catarrh and cancers like melanoma or squamous cell carcinoma manage their symptoms."

Answered by AI

How many sites have been chosen to host this clinical experiment?

"Currently, this medical research is being conducted at 5 distinct sites. The cities offering these services are Goshen, Tacoma and Austin with two other locations yet to be disclosed. To minimize travel time for participating patients, it would wise to select the nearest available location."

Answered by AI

What is the participant recruitment rate for this experiment?

"As of now, this trial is not taking on any new patients. It was first posted on March 26th 2021 and last amended October 6th 2022. Though this study cannot accommodate you at the moment, there are several other trials actively recruiting; 470 for solid tumors and advanced metastatic cases, with 871 solely devoted to Sitravatinib treatments alone."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates
2021. "PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04887194.
~10 spots leftby Apr 2025
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