Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT01637961
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2012-07-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Evaluation of MLN8237 (NSC# 747888) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Status:
COMPLETED
Status Verified Date:
2019-07
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 studies how well alisertib works in treating patients with leiomyosarcoma of the uterus that has come back or persistent. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the clinical activity of MLN8237 (alisertib) in patients with recurrent or persistent leiomyosarcoma of the uterus who have received one or two prior cytotoxic therapies and the frequency of patients who survive progression-free for at least 6 months after initiating therapy or have objective tumor response.
SECONDARY OBJECTIVES:
I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) among women with leiomyosarcoma treated with MLN8237.
II. To determine the distribution of progression-free survival (PFS) and overall survival (OS).
TERTIARY OBJECTIVES:
I. To determine the relationship of Aurora A Kinase expression, measured by immunohistochemistry, with objective response, PFS at 6 months, survival, and progression-free survival.
OUTLINE:
Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
I. To assess the clinical activity of MLN8237 (alisertib) in patients with recurrent or persistent leiomyosarcoma of the uterus who have received one or two prior cytotoxic therapies and the frequency of patients who survive progression-free for at least 6 months after initiating therapy or have objective tumor response.
SECONDARY OBJECTIVES:
I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) among women with leiomyosarcoma treated with MLN8237.
II. To determine the distribution of progression-free survival (PFS) and overall survival (OS).
TERTIARY OBJECTIVES:
I. To determine the relationship of Aurora A Kinase expression, measured by immunohistochemistry, with objective response, PFS at 6 months, survival, and progression-free survival.
OUTLINE:
Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study Oversight
Has Oversight DMC:
True
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-2012-01982 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| GOG-0231D | None | None | View | |
| CDR0000736350 | None | None | View | |
| GOG-0231D | OTHER | NRG Oncology | View | |
| GOG-0231D | OTHER | CTEP | View | |
| U10CA180868 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA027469 | NIH | None | https://reporter.nih.gov/quic… | View |