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Tyrosine Kinase Inhibitor

Sitravatinib Combination Therapy for Solid Cancers

Phase 2 & 3

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

Must not have

Known or suspected presence of other cancer

Other life-threatening illness or organ system dysfunction compromising safety evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug, sitravatinib, to see if it works better than other cancer drugs currently available.

Who is the study for?

This trial is for patients already benefiting from Sitravatinib alone or with other cancer drugs in a previous study, without severe side effects or another life-threatening illness. The doctor must believe continuing treatment is good for the patient.

What is being tested?

The study tests if Sitravatinib, on its own or combined with drugs like Ipilimumab, Nivolumab, Pembrolizumab, and Enfortumab Vedotin-Ejfv helps advanced solid tumors. It's for those who saw benefits in an earlier Mirati-sponsored trial.

What are the potential side effects?

Possible side effects include immune system reactions that can affect organs, infusion-related symptoms, fatigue, skin issues and potential complications from combining multiple treatments.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I may have another type of cancer besides the one being treated.

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I do not have any severe illnesses that could affect my safety in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of subjects experiencing treatment-related AEs.

Secondary study objectives

Time to clinical or radiographic progression on study.

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%

Pain

29%

Hypothyroidism

29%

Vomiting

29%

Diarrhoea

29%

Hypotension

29%

Myalgia

29%

Urinary tract infection

29%

Amylase increased

14%

Chills

14%

Herpes zoster

14%

Acute respiratory failure

14%

Flank pain

14%

Cough

14%

Alanine aminotransferase increased

14%

Epistaxis

14%

Night sweats

14%

Weight decreased

14%

Abdominal pain

14%

Arthralgia

14%

Hyperuricaemia

14%

Memory impairment

14%

Musculoskeletal pain

14%

Nasal congestion

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%

Urosepsis

14%

Atrial fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

Sitravatinib 120 mg

Sitravatinib 80 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase 2/3: Open label extension of parent studyExperimental Treatment5 Interventions

The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3070

Sitravatinib

2017

Completed Phase 2

~510