Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125827
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2005-07-29
Brief Title:
Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase I Dose Escalation and Pharmacokinetic Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-03
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:
Clofarabine injection is approved by the Food and Drug Administration FDA for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia ALL who have had at least 2 prior treatment regimens
This is a research study of clofarabine that will be given to patients orally with advanced cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer effective or no reliable effective treatment is available
The purpose of this study is to find the answers to the following research questions
1 What is the largest dose of oral clofarabine that can be safely given daily for 5 days followed by 23 days of rest and repeated every 28 days
2 What are the side effects of clofarabine when given on this schedule
3 How much oral clofarabine is in the blood at specific times after administration and how does the body get rid of the drug
4 Will oral clofarabine help treat solid tumor cancer
This is a research study of clofarabine that will be given to patients orally with advanced cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer effective or no reliable effective treatment is available
The purpose of this study is to find the answers to the following research questions
1 What is the largest dose of oral clofarabine that can be safely given daily for 5 days followed by 23 days of rest and repeated every 28 days
2 What are the side effects of clofarabine when given on this schedule
3 How much oral clofarabine is in the blood at specific times after administration and how does the body get rid of the drug
4 Will oral clofarabine help treat solid tumor cancer
Detailed Description:
None
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