Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-25 @ 4:13 PM
Study NCT ID:
NCT04168957
Status:
TERMINATED
Last Update Posted:
2022-03-03
First Post:
2018-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007
Sponsor:
Athenex, Inc.
Organization:
Study Overview
Official Title:
An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No need to complete the overall survival (OS) follow-up as the sample size was too small to interpret OS.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
KX-ORAX-008 is an extension study of patients who completed KX-ORAX-007 without disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and who wish to continue Oraxol treatment.
Detailed Description:
This is a multicenter, open-label, extension study offering the option of further Oraxol treatment to breast cancer patients who have completed the KX-ORAX-007 Oraxol study with complete response (CR), partial response (PR), or stable disease (SD), and who wish to continue further Oraxol treatment. The study contains 3 periods: the Screening Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1180-5217 | OTHER | ICTRP | View |