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Tyrosine Kinase Inhibitor

Zanzalintinib for Leiomyosarcoma

Phase 2

Recruiting

Led By Seth M Pollack, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have undergone > 2 prior lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor

Patients must exhibit a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or > 70% on the Karnofsky Scale

Must not have

The patient has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders: Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes), Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic of > 90 mm Hg diastolic despite optimal antihypertensive treatment, Stroke (including transient ischemic attack [TIA]), myocardial infarction, or other clinically significant ischemic events within 12 months prior to first dose of study treatment. Note: Patients who did not require prior anticoagulant therapy may be eligible must be discussed and approved by the principal investigator (PI), Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-cerebrovascular accident (CVA)/TIA arterial thromboembolic events within 6 months before to first dose of study treatment., Prior history of myocarditis. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: Tumors invading the GI tract from external viscera, Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis, Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess must be confirmed prior to first dose of study treatment, Known gastric or esophageal varices, Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless cause of obstruction is definitively managed and subject is asymptomatic, Patients with clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 84 days prior to registration, Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation, Lesions invading major blood vessel including but not limited to inferior vena cava, pulmonary artery, or aorta. Note: Patients with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior vena cava) may be eligible following PI approval, Patients who are capable of donating eggs for the purpose of reproduction must not do so throughout the course of the study and for 186 days after the last dose of treatment, Patients who are capable of donating sperm for the purpose of reproduction must not do so throughout the course of the study and for 96 days after the last dose of treatment, Other clinically significant disorders that would preclude safe study participation, including, but not limited to: Active infection requiring systemic treatment. Note: This criterion applies only at enrollment; if a patient develops an infection while on study treatment, they may continue to receive study treatment. Note: prophylactic antibiotic treatment is allowed, Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness, Known positive test for or suspected infection with SARS-CoV-2 within one month prior to enrollment. Note: Demonstration that the patient has fully recovered from the infection is required to be eligible for enrollment, Serious non-healing wound/ulcer/bone fracture. Note: non-healing wounds or ulcers are permitted if they are due to tumor-associated skin lesions, Malabsorption syndrome, Pharmacologically uncompensated, symptomatic hypothyroidism, Moderate to severe hepatic impairment (Child-Pugh B or C), Requirement for hemodialysis or peritoneal dialysis, History of solid organ or allogenic stem cell transplant, Recent surgery within the following parameters: Major surgery (e.g., GI surgery or removal/biopsy of brain metastasis) within 8 weeks prior to study treatment, Minor surgery (e.g., simple excision, tooth extraction) within 10 days prior to first dose of study treatment. Note: if a patient has had a recent surgery outside of the proscribed interval, complete wound healing from said surgery must have occurred prior to first dose of study treatment. Note: Fresh tumor biopsies should be performed at least 7 days prior to registration. Patients with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible, Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms within 14 days per electrocardiogram (ECG) prior to first dose of study treatment Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility, Patients with any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) grade ≥ 1 at baseline from a previous anticancer therapy, with the following exceptions: Alopecia, vitiligo, and the laboratory values, Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician, Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with XL092 may be included only after consultation with the principal investigator, Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to XL092, Patients who are pregnant (positive serum or urine test within 72 hours prior to enrollment) or nursing. Pregnant people are excluded from this study because XL092 is a next-generation tyrosine kinase inhibitor with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing parent with XL092, breastfeeding should be discontinued if the nursing parent is treated with XL092. Note: If a urine pregnancy test is positive or cannot be confirmed negative, a serum pregnancy test will be required, Patients with psychiatric illness/social situations that would limit compliance with study requirements, per the opinion of the treating investigator, XL092 is administrated orally; patients who are unable to swallow, retain, and/or absorb pills are not eligible for this study, Patients who are currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of treatment, Other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study

Patients who have received > 2 prior tyrosine kinase inhibitor therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a drug called XL092 in patients with leiomyosarcoma that has spread or cannot be removed by surgery. Leiomyosarcoma is a type of cancer that can occur

Who is the study for?

This trial is for patients with leiomyosarcoma, a type of sarcoma that has spread or can't be removed by surgery. Participants must meet certain health conditions to join, but specific inclusion and exclusion criteria are not provided in the given information.

What is being tested?

The trial is testing XL092 (Zanzalintinib), which may interfere with tumor growth in metastatic or unresectable leiomyosarcoma. It's a phase II study to see if this drug can improve survival compared to current treatments.

What are the potential side effects?

Possible side effects are not detailed here, but as XL092 is a tyrosine kinase inhibitor, common side effects might include fatigue, nausea, diarrhea, skin rash and increased blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had more than 2 cancer treatments, but no more than 2 were tyrosine kinase inhibitors.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My white blood cell count is healthy without needing medication to boost it.

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My leiomyosarcoma is confirmed and cannot be surgically removed or has spread.

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I am 18 years old or older.

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My hemoglobin level is at least 9 g/dL without recent transfusions.

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My platelet count is above 100,000 without recent transfusions.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

Exclusion Criteria

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

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I have had more than two prior treatments with tyrosine kinase inhibitors.

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I haven't had radionuclide treatment in the last 6 weeks.

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I have previously been treated with XL092.

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I am on blood thinners but can stop them as required before starting the study.

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I received radiation for bone metastasis less than 14 days ago.

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

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

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Duration of response (DOR)

Incidence of adverse events (AEs)

Median PFS

+2 more

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: Treatment (XL092)Experimental Treatment5 Interventions

Patients receive XL092 PO QD on days 1-14 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA at screening and then as clinically indicated, and blood sample collection on study and CT throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiography

2013

Completed Phase 4

~11580

Biospecimen Collection

2004

Completed Phase 3

~2030