Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-04-09 @ 6:30 AM
Study NCT ID:
NCT00109356
Status:
UNKNOWN
Last Update Posted:
2007-05-07
First Post:
2005-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AQ4N in Patients With Non Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia
Sponsor:
Novacea
Organization:
Study Overview
Official Title:
A Phase 1/2, Open Label, Dose Escalation Study of AQ4N for Safety, Tolerability, Pharmacokinetics and Activity in Patients With Lymphoid Neoplasms
Status:
UNKNOWN
Status Verified Date:
2007-05
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 purpose of this study is to find answers to the following questions:
* What is the largest dose of AQ4N that can be given safely one time every three weeks for 24 weeks?
* What are the side effects of AQ4N when given according to this schedule?
* How much AQ4N is in the blood at certain times after administration and how does the body get rid of the drug?
* Will AQ4N help treat lymphoid cancer?
* What is the largest dose of AQ4N that can be given safely one time every three weeks for 24 weeks?
* What are the side effects of AQ4N when given according to this schedule?
* How much AQ4N is in the blood at certain times after administration and how does the body get rid of the drug?
* Will AQ4N help treat lymphoid cancer?
Detailed Description:
All patients in this study will receive AQ4N one time every three weeks for a maximum of 24 weeks. Each patient will receive the same dose for the entire time he/she is on the study. However, some patients may receive a different dose than other patients depending upon when they enter the study.
When the study begins, the first three patients will receive a dose of 400 mg/m2. After they have all been observed for 2 weeks, and if side effects do not occur or are tolerable, another three patients will enter the study at a higher dose. The increase in dose may continue with new patient groups until side effects reach a point where they are not tolerated. At that point no higher doses will be tried and more patients will be allowed to enter at one or two lower doses where the side effects were tolerated.
Up to 55 patients will be entered in this study at up to 8 research centers in the United States. Study duration will be approximately 27 weeks or 8 treatment cycles (One treatment cycle lasts 3 weeks and begins on Day 1 with an infusion of AQ4N.)
The following procedures will be completed at the time of screening and throughout the study: review of medical and cancer history, previous cancer treatments, and current medications, a complete physical exam, and blood (4 to 6 teaspoons) and urine tests. Two additional tests to evaluate the heart, an electrocardiogram (ECG) and a multiple gated acquisition assessment (MUGA) will be performed. Cancer progression will be monitored by a computed tomography scan (CT scan) and a bone marrow biopsy.
When the study begins, the first three patients will receive a dose of 400 mg/m2. After they have all been observed for 2 weeks, and if side effects do not occur or are tolerable, another three patients will enter the study at a higher dose. The increase in dose may continue with new patient groups until side effects reach a point where they are not tolerated. At that point no higher doses will be tried and more patients will be allowed to enter at one or two lower doses where the side effects were tolerated.
Up to 55 patients will be entered in this study at up to 8 research centers in the United States. Study duration will be approximately 27 weeks or 8 treatment cycles (One treatment cycle lasts 3 weeks and begins on Day 1 with an infusion of AQ4N.)
The following procedures will be completed at the time of screening and throughout the study: review of medical and cancer history, previous cancer treatments, and current medications, a complete physical exam, and blood (4 to 6 teaspoons) and urine tests. Two additional tests to evaluate the heart, an electrocardiogram (ECG) and a multiple gated acquisition assessment (MUGA) will be performed. Cancer progression will be monitored by a computed tomography scan (CT scan) and a bone marrow biopsy.
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?: