Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT06571734
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
A Single-Arm, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
PRIMARY OBJECTIVE:
I. Evaluate 6-month progression-free survival (PFS) of patients with advanced leiomyosarcoma (LMS) who have been treated with zanzalintinib (XL092) monotherapy.
SECONDARY OBJECTIVES:
I. Evaluate median progression-free survival (PFS) in patients with advanced LMS who have been treated with XL092 monotherapy.
II. Determine overall survival (OS) in patients with advanced LMS who have been treated with XL092 monotherapy.
III. Determine overall response rate (ORR) in patients with advanced LMS who have been treated with XL092 monotherapy.
IV. Assess duration of response (DOR) in patients with advanced LMS who have been treated with XL092 monotherapy.
V. Assess toxicity of XL092 in patients with advanced LMS who have been treated with such as monotherapy.
OUTLINE:
Patients receive XL092 orally (PO) once daily (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 echocardiography (ECHO) or multigated acquisition scan (MUGA) at screening and then as clinically indicated, and blood sample collection on study and computed tomography (CT) throughout the study.
After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for 2 years followed by every 6 months for up to 5 years from start of study treatment.
I. Evaluate 6-month progression-free survival (PFS) of patients with advanced leiomyosarcoma (LMS) who have been treated with zanzalintinib (XL092) monotherapy.
SECONDARY OBJECTIVES:
I. Evaluate median progression-free survival (PFS) in patients with advanced LMS who have been treated with XL092 monotherapy.
II. Determine overall survival (OS) in patients with advanced LMS who have been treated with XL092 monotherapy.
III. Determine overall response rate (ORR) in patients with advanced LMS who have been treated with XL092 monotherapy.
IV. Assess duration of response (DOR) in patients with advanced LMS who have been treated with XL092 monotherapy.
V. Assess toxicity of XL092 in patients with advanced LMS who have been treated with such as monotherapy.
OUTLINE:
Patients receive XL092 orally (PO) once daily (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 echocardiography (ECHO) or multigated acquisition scan (MUGA) at screening and then as clinically indicated, and blood sample collection on study and computed tomography (CT) throughout the study.
After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for 2 years followed by every 6 months for up to 5 years from start of study treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-06742 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STU00221266 | None | None | View | |
| NU 23S03 | OTHER | Northwestern University | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |