Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-01-03 @ 5:59 AM
Study NCT ID:
NCT00090727
Status:
UNKNOWN
Last Update Posted:
2006-11-02
First Post:
2004-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Sponsor:
Novacea
Organization:
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:
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?: