Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109356
Status:
UNKNOWN
Last Update Posted:
2007-05-07
First Post:
2005-04-27
Brief Title:
Study of AQ4N in Patients With Non Hodgkins Lymphoma Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia
Sponsor:
Novacea
Organization:
Novacea
Study Overview
Official Title:
A Phase 12 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 heshe 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 mgm2 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 mgm2 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:
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