Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00132002
Status:
TERMINATED
Last Update Posted:
2015-03-19
First Post:
2005-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Suberoylanilide Hydroxamic Acid in Treating Patients With Progressive Stage IV Breast Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) (NSC 701852) as Salvage Therapy in Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early termination for discouraging results
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 is studying how well suberoylanilide hydroxamic acid works in treating patients with progressive stage IV breast cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the response rate in patients receiving SAHA for stage IV breast cancer.
SECONDARY OBJECTIVES:
I. Time to progression. II. Overall survival. III. Toxicity profile. IV. Assessment of potential biological correlates.
OUTLINE: This is a multicenter study.
Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 8 weeks.
I. To evaluate the response rate in patients receiving SAHA for stage IV breast cancer.
SECONDARY OBJECTIVES:
I. Time to progression. II. Overall survival. III. Toxicity profile. IV. Assessment of potential biological correlates.
OUTLINE: This is a multicenter study.
Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 8 weeks.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PHII-62 | None | None | View | |
| N01CM62209 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000438776 | REGISTRY | PDQ (Physician Data Query) | View |