Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-31 @ 12:33 AM
Study NCT ID:
NCT00357032
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2006-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PXD101 in Treating Patients With Acute Myeloid Leukemia
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Study of PXD101 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or Patients Over 60 With Newly-Diagnosed Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2018-03
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 is studying how well PXD101 works in treating patients with relapsed or refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid leukemia. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. Evaluate the response rate (complete response and partial response) in patients with acute myeloid leukemia treated with PXD101.
SECONDARY OBJECTIVES:
I. Evaluate the overall survival of these patients. II. Evaluate the duration of response in these patients. III. Evaluate the toxicity of this drug in these patients.
TERTIARY OBJECTIVES:
I. Evaluate molecular response to PXD101.
OUTLINE:
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
Blood and bone marrow samples are obtained before and after study treatment for laboratory studies.
After completion of study treatment, patients are followed periodically for 1 year.
I. Evaluate the response rate (complete response and partial response) in patients with acute myeloid leukemia treated with PXD101.
SECONDARY OBJECTIVES:
I. Evaluate the overall survival of these patients. II. Evaluate the duration of response in these patients. III. Evaluate the toxicity of this drug in these patients.
TERTIARY OBJECTIVES:
I. Evaluate molecular response to PXD101.
OUTLINE:
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
Blood and bone marrow samples are obtained before and after study treatment for laboratory studies.
After completion of study treatment, patients are followed periodically for 1 year.
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-68 | None | None | View | |
| N01CM62209 | NIH | None | https://reporter.nih.gov/quic… | View |