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Tyrosine Kinase Inhibitor

Sitravatinib in Metastatic Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Xiang Zhang
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 up to 16 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests sitravatinib, a pill taken regularly, in patients with advanced breast cancer. The medication aims to stop the cancer from getting worse by blocking proteins that help cancer cells grow.

Eligible Conditions
  • Breast Cancer
  • Breast cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 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
Efficacy: Progression-Free Survival at 24 Weeks (PFS24)
Secondary study objectives
Clinical Benefit Rate (CBR)
Number of Participants With Grade 3 or Higher AEs
Objective Response Rate (ORR)
+1 more

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
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Dry mouth
7%
anemia
7%
Gastroesophageal reflux disease
7%
Fall
7%
Erectile dysfunction
7%
Hypersomnia
7%
Watering eyes
7%
Blurred vision
7%
Irritability
7%
Conjunctivitis
7%
appendicitus
7%
Hyperthyroidism
7%
Oral dysesthesia
7%
Urinary urgency
7%
Respiratory, thoracic and mediastinal disorders - Other, specify
7%
abodominal pain
7%
Laryngeal hemorrhage
7%
Upper gastrointestinal hemorrhage
7%
Sinus tachycardia
7%
Tinnitus
7%
Hepatobiliary disorders - Other, specify
7%
Infections and infestations - Other, specify
7%
Seroma
7%
Cardiac troponin I increased
7%
Hemoglobin increased
7%
Hypercalcemia
7%
Concentration impairment
7%
Nervous system disorders - Other, specify
7%
Depression
7%
Chronic kidney disease
7%
Urinary retention
7%
Epistaxis
7%
Hyperhidrosis
7%
Photosensitivity
7%
Lymphocele
7%
Bone pain
7%
Muscle weakness lower limb
7%
Neck pain
7%
Pain in extremity
7%
bronchial obsturction
7%
Localized edema
7%
Blood and lymphatic system disorders - Other, specify
7%
Abdominal distension
7%
Hematuria
7%
Sneezing
7%
Pain of skin
7%
Phlebitis
7%
Oral pain
7%
Malaise
7%
Dehydration
7%
Hot flashes
100%
80%
60%
40%
20%
0%
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: SitravatinibExperimental Treatment1 Intervention
Sitravatinib 100 mg daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitravatinib
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Xiang ZhangLead Sponsor
1 Previous Clinical Trials
64 Total Patients Enrolled
Mirati Therapeutics Inc.Industry Sponsor
70 Previous Clinical Trials
8,126 Total Patients Enrolled
1 Trials studying Breast Cancer
54 Patients Enrolled for Breast Cancer
C. Kent Osborne, MDLead Sponsor
Maryam Nemati ShafaeeLead Sponsor
~1 spots leftby Dec 2025
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