Zanzalintinib for Leiomyosarcoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Northwestern University
Must not be taking: Anticoagulants, Platelet inhibitors, Herbal supplements
Disqualifiers: Brain metastases, Uncontrolled hypertension, Active infection, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase II trial tests how well zanzalintinib (XL092) works in treating patients with leiomyosarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Leiomyosarcomas are a type sarcoma that can occur in any location in the body, such as the uterus or in the abdomen. Current standard treatment for leiomyosarcoma only shows a progression-free survival of 4-6 months. XL092, a tyrosine kinase inhibitor, interferes with cell communication and growth and may prevent tumor growth. Giving XL092 may kill more tumor cells in patients with metastatic or unresectable leiomyosarcoma.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot take certain medications like small-molecule kinase inhibitors within 14 days before starting the trial. You also need to stop taking oral anticoagulants at least 3 days before the trial. It's best to discuss your specific medications with the trial team.
What makes the drug Zanzalintinib unique for treating leiomyosarcoma?
Zanzalintinib (XL092) is a novel treatment option for leiomyosarcoma, a condition with limited effective therapies. Unlike traditional treatments that often rely on cytotoxic agents like doxorubicin, Zanzalintinib may offer a new mechanism of action, potentially addressing the unmet medical need for more effective systemic therapies in this challenging condition.
12345Eligibility Criteria
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.Inclusion Criteria
I've had more than 2 cancer treatments, but no more than 2 were tyrosine kinase inhibitors.
I am fully active or restricted in physically strenuous activity but can do light work.
Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
+21 more
Exclusion Criteria
I haven't taken any kinase inhibitor medication in the last 14 days.
I have had more than two prior treatments with tyrosine kinase inhibitors.
I am receiving ongoing treatment for side effects from previous radiation therapy.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive XL092 orally once daily on days 1-14 of each cycle, with cycles repeating every 14 days
Up to 6 months
Bi-weekly visits for treatment and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Up to 5 years
Follow-up at 30 days, then every 12 weeks for 2 years, followed by every 6 months
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern UniversityChicago, IL
Loading ...
Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
A phase 2 study of alisertib (MLN8237) in recurrent or persistent uterine leiomyosarcoma: An NRG Oncology/Gynecologic Oncology Group study 0231D. [2021]This two-stage Phase II study assessed the activity of single agent alisertib in patients with recurrent/persistent uterine leiomyosarcoma (uLMS).
A case of pembrolizumab and lenvatinib as an alterntive therapy for leiomyosarcoma. [2023]•Research surrounding treatment of leiomyosarcoma (LMS) treatment remains sparse.•Pembrolizumab/lenvatinib has been reported as a therapy for endometrial cancer, though not yet as therapy for LMS.•This report demonstrates disease regression after use of pembrolizumab and lenvatinib in a patient with recurrent LMS.
What Clinical Trials Are Needed for Treatment of Leiomyosarcoma? [2022]Leiomyosarcoma is one of the most common subtypes of soft tissue sarcomas accounting for approximately 20% of sarcomas. As leiomyosarcoma patients frequently develop metastatic disease, effective systemic therapies are needed to improve clinical outcomes. The overall activity of the currently available conventional systemic therapies and the prognosis of patients with advanced and/or metastatic disease are poor. As such, the treatment of this patient population remains challenging. As a result, there is a clear unmet medical need, and designing and performing meaningful clinical studies are of utmost importance to improve the prognosis of this patient group. Therefore, the aim of this review is to briefly summarize state-of-the-art treatments for leiomyosarcoma patients and to describe trial characteristics needed for informative clinical studies.
PD-1 Inhibition in metastatic high tumour mutational burden (TMB) leiomyosarcoma with clinicopathological correlates. [2023]Leiomyosarcoma (LMS) is a subtype of sarcoma derived from smooth muscle cells. Unfortunately, this malignancy has a high rate of metastatic disease. Palliative systemic therapy has historically relied on cytotoxic agents such as doxorubicin, which have low rates of response. Immunotherapy has not been shown to be effective for most patients with sarcoma, including those with LMS. However, this has not been well described for patients with LMS and high tumour mutational burden (TMB). Herein, we report the case of a woman in her late 50s with metastatic high TMB (>10) leiomyosarcoma treated with pembrolizumab.
Elimusertib (BAY1895344), a novel ATR inhibitor, demonstrates in vivo activity in ATRX mutated models of uterine leiomyosarcoma. [2023]Uterine leiomyosarcoma (uLMS) is a rare, highly aggressive malignancy. Recent data suggest 50% of uLMS may harbor alterations in the ATRX gene and such mutations may confer sensitivity to ataxia-telangiectasia-and-Rad3-related (ATR) kinase inhibitors. We sought to investigate the in vivo activity of Elimusertib (BAY1895344), a novel ATR-inhibitor, against ATRX-mutated uLMS patient-derived xenografts (PDXs).