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Tyrosine Kinase Inhibitor

Sitravatinib for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by C. Kent Osborne, MD

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 5 years

Awards & highlights

Study Summary

This trial is testing a new drug, sitravatinib, to see if it can help people with metastatic breast cancer. Everyone in the study will take sitravatinib daily to see if it can help their cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Benefit Rate

Secondary outcome measures

Number of patients with Grade 3 or higher adverse events

Time to Progression

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%

Hypotension

29%

Hypothyroidism

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%

Study treatment Arm

Sitravatinib 120 mg

Sitravatinib 80 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: SitravatinibExperimental Treatment1 Intervention

Sitravatinib 120 mg daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sitravatinib

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Industry Sponsor

70 Previous Clinical Trials

8,255 Total Patients Enrolled

1 Trials studying Breast Cancer

54 Patients Enrolled for Breast Cancer

C. Kent Osborne, MDLead Sponsor

Maryam Nemati ShafaeeLead Sponsor

Frequently Asked Questions

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

To what extent is participation being solicited for this research?

"Yes, the information on clinicaltrials.gov illustrates that this examination is actively recruiting participants. This research was initially made available on May 24th 2021 with its most recent update occurring June 1st 2021 and is accepting a total of 30 patients at one centre."

Answered by AI

Are there vacancies for volunteers in this clinical exploration?

"Affirmative. According to the clinicaltrials.gov database, this medical trial is actively recruiting subjects with its initial post being on May 24th 2021 and was most recently updated June 1st 2021. 30 individuals are required at a single location for the study to move forward."

Answered by AI

What risks have been associated with Sitravatinib treatment?

"Our firm's assessment of sitravatinib's safety was contained to a 2, as this phase 2 trial has only provided limited evidence for its effectiveness and no data on potential risks."

Answered by AI

Is this investigation the inaugural attempt at such a therapeutic approach?

"Since the start of 2015, Sitravatinib has been under intense scrutiny by researchers. Mirati Therapeutics Inc. initially sponsored a study involving 423 patients that year and consequently granted it Phase 2 drug approval following its successful completion. Nowadays there are 16 simultaneous trials for this medication being conducted in 217 cities across 14 countries."

Answered by AI

Are there records of any former experiments involving Sitravatinib?

"At the moment, 16 trials are researching Sitravatinib's efficacy. Of those studies, three have advanced to Phase 3 testing. New Haven Connecticut is noted as a key research hub for this medication; however there are hundreds of other sites across the country participating in its clinical trial process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sitravatinib in Metastatic Breast Cancer

C. Kent Osborne, MD 2021. "Sitravatinib in Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04123704.