Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-23 @ 1:44 PM
Study NCT ID:
NCT01935934
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2013-09-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2025-09
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 studies how well cabozantinib s-malate works in treating patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine efficacy of single agent cabozantinib s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS).
SECONDARY OBJECTIVES:
I. Correlation of clinical response with baseline molecular status of archival tumor (hepatocyte growth factor receptor \[c-met\] amplification \& mutation status) and overall survival.
OUTLINE:
Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks or every 6 months.
I. Determine efficacy of single agent cabozantinib s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS).
SECONDARY OBJECTIVES:
I. Correlation of clinical response with baseline molecular status of archival tumor (hepatocyte growth factor receptor \[c-met\] amplification \& mutation status) and overall survival.
OUTLINE:
Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks or every 6 months.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-00890 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| PHL-086 | None | None | View | |
| 9322 | OTHER | University Health Network-Princess Margaret Hospital | View | |
| 9322 | OTHER | CTEP | View | |
| N01CM00032 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM00038 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM00071 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186644 | NIH | None | https://reporter.nih.gov/quic… | View |