Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090727
Status:
UNKNOWN
Last Update Posted:
2006-11-02
First Post:
2004-09-02
Brief Title:
Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkins Lymphoma
Sponsor:
Novacea
Organization:
Novacea
Study Overview
Official Title:
A Phase 1 Open-Label Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies
Status:
UNKNOWN
Status Verified Date:
2005-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are to determine
the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle
the side effects of AQ4N when given on the above schedule
how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N
if AQ4N helps treat cancer
the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle
the side effects of AQ4N when given on the above schedule
how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N
if AQ4N helps treat cancer
Detailed Description:
This study is for people who have advanced cancer for which standard chemotherapy did not work or for which there are no reliably effective treatments
AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment AQ4N may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide causing tumors to die or to delay their growth
All patients in this study will receive AQ4N The dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached
AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment AQ4N may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide causing tumors to die or to delay their growth
All patients in this study will receive AQ4N The dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached
Study Oversight
Has Oversight DMC:
None
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?:
None