Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571734
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
XL092 Zanzalintinib for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Arm Open-label Phase II Trial Testing the Activity of XL092 Zanzalintinib in Patients With Advanced Leiomyosarcoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None