Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345540
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2006-06-26
Brief Title:
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer
Sponsor:
Cellectar Biosciences Inc
Organization:
Cellectar Biosciences Inc
Study Overview
Official Title:
Phase 2 Trial of NOV-002 With Carboplatin in Women With Recurrent and Platinum Resistant Tumors of Mullerian Origin
Status:
COMPLETED
Status Verified Date:
2009-01
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:
The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin in a cohort of women with platinum resistant cancer of ovarian origin
Detailed Description:
The purpose of this research study is to learn if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer Platinum containing drugs such as carboplatin are the standard treatment for ovarian cancer and are effective for many women However in many women the cancer eventually stops responding to the chemotherapy becomes resistant
The active part of NOV-002 is a substance made by the body that is involved in many chemical reactions in cells NOV-002 does not directly kill cancer cells but previous research has shown that it may make cancer cells more likely to be killed by chemotherapy drugs Specifically it may help platinum chemotherapy kill cancer that has become resistant to platinum chemotherapy Previous trials have also shown that patients receiving NOV-002 in addition to carboplatin may have tolerated chemotherapy better than those who received chemotherapy alone NOV-002 has been used in other research studies on various types of cancer It is approved for use in Russia It is not approved by the US Food and Drug Administration FDA for use outside of research studies
In this research study the investigators are looking to see if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer in women whose cancer has stopped responding to carboplatin chemotherapy alone
The active part of NOV-002 is a substance made by the body that is involved in many chemical reactions in cells NOV-002 does not directly kill cancer cells but previous research has shown that it may make cancer cells more likely to be killed by chemotherapy drugs Specifically it may help platinum chemotherapy kill cancer that has become resistant to platinum chemotherapy Previous trials have also shown that patients receiving NOV-002 in addition to carboplatin may have tolerated chemotherapy better than those who received chemotherapy alone NOV-002 has been used in other research studies on various types of cancer It is approved for use in Russia It is not approved by the US Food and Drug Administration FDA for use outside of research studies
In this research study the investigators are looking to see if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer in women whose cancer has stopped responding to carboplatin chemotherapy alone
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