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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:

Select...

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 2022 Phase 1 & 2 trial • 42 Patients • NCT03015740

87%

Anemia

87%

Hyperglycemia

87%

Hypertriglyceridemia

80%

Investigations - Other, specify

80%

Creatinine increased

80%

Weight loss

80%

Fatigue

73%

Diarrhea

73%

Anorexia

73%

Lipase increased

67%

Lymphocyte count decreased

67%

Serum amylase increased

67%

Proteinuria

67%

Cough

60%

Hypertension

53%

Abdominal pain

53%

Constipation

53%

Nausea

47%

Cholesterol high

47%

Vomiting

47%

Alanine aminotransferase increased

47%

Hyperkalemia

47%

Hoarseness

47%

Rash acneiform

47%

Back pain

40%

Pain

40%

Aspartate aminotransferase increased

40%

Hypoalbuminemia

40%

Dyspnea

40%

Mucositis oral

40%

Arthralgia

40%

Myalgia

33%

Metabolism and nutrition disorders - Other, specify

33%

Hyponatremia

33%

Hypophosphatemia

33%

INR increased

33%

Dizziness

33%

Headache

33%

Edema Limbs

33%

Activated partial thromboplastin time prolonged

33%

Alkaline phosphatase increased

33%

Hypomagnesemia

33%

Insomnia

33%

Postnasal drip

33%

Endocrine disorders - Other, specify

27%

Sinusitis

27%

Hypothyroidism

27%

Rash maculo-papular

27%

Skin and subcutaneous tissue disorders - Other, specify

27%

Hypocalcemia

20%

Allergic rhinitis

20%

Urinary frequency

20%

Anxiety

20%

Nasal congestion

20%

Wheezing

20%

Fever

20%

Bruising

20%

Dry skin

13%

Hypoglycemia

13%

Pruritus

13%

Non-cardiac chest pain

13%

Productive cough

13%

Flu like symptoms

13%

White blood cell decreased

13%

Ear pain

13%

Surgical and medical procedures - Other, specify

13%

Generalized muscle weakness

13%

Hypernatremia

13%

Vertigo

13%

Gastrointestinal disorders - Other, specify

13%

Pancreatitis

13%

Chills

13%

Cardiac disorders - Other, specify

13%

Blood bilirubin increased

13%

Hypokalemia

13%

Paresthesia

13%

Thromboembolic event

13%

Arthritis

13%

Urinary tract infection

13%

Atrial fibrillation

13%

Gait disturbance

13%

Platelet count decreased

13%

Renal and urinary disorders - Other, specify

13%

Sore throat

13%

Palmar-plantar erythrodysesthesia syndrome

Dry mouth

anemia

Gastroesophageal reflux disease

Erectile dysfunction

Hypersomnia

Watering eyes

Blurred vision

Irritability

Conjunctivitis

Fall

Respiratory, thoracic and mediastinal disorders - Other, specify

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

appendicitus

Hyperthyroidism

Oral dysesthesia

Urinary urgency

abodominal pain

Laryngeal hemorrhage

Upper gastrointestinal hemorrhage

Sinus tachycardia

Tinnitus

Hepatobiliary disorders - Other, specify

Infections and infestations - Other, specify

Seroma

Cardiac troponin I increased

Hemoglobin increased

Hypercalcemia

Concentration impairment

Nervous system disorders - Other, specify

Depression

Chronic kidney disease

Urinary retention

Epistaxis

Hyperhidrosis

Photosensitivity

Lymphocele

Bone pain

Muscle weakness lower limb

Neck pain

Pain in extremity

bronchial obsturction

Localized edema

Blood and lymphatic system disorders - Other, specify

Abdominal distension

Hematuria

Sneezing

Pain of skin

Phlebitis

Oral pain

Malaise

Dehydration

Hot flashes

100%

80%

60%

40%

20%

Study treatment Arm

Received Sitravatinib 80 mg in Combination With Nivolumab

Received Sitravatinib 120 mg in Combination With Nivolumab

Received Sitravatinib 150 mg in Combination With Nivolumab

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

~3420

Sitravatinib

2017

Completed Phase 2

~510