Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138658
Status:
COMPLETED
Last Update Posted:
2012-02-06
First Post:
2005-08-26
Brief Title:
A Study of OGX-011GemcitabinePlatinum-Based Regimen in Stage IIIBIV Non-Small Cell Lung Cancer NSCLC
Sponsor:
Achieve Life Sciences
Organization:
Achieve Life Sciences
Study Overview
Official Title:
A Phase 1-2 Study of Weekly OGX-011 Plus a GemcitabinePlatinum-Based Regimen in Patients With Stage IIIB or IV Non Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-02
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:
This clinical study will help determine if giving OGX-011 custirsen sodium in combination with gemcitabine GEM and cisplatin CIS or carboplatin CARB is a safe and effective treatment for patients with lung cancer This study will help to assess the safety and anti-tumor effect of OGX-011 when given to patients in combination with GEM and CISCARB
Detailed Description:
OGX-011 is an experimental drug that has been shown to increase the effectiveness of commonly used cancer therapies such as chemotherapy radiation and hormone therapy in several kinds of cancer types in animals OGX-011 is being studied in the treatment of cancer patients in combination with chemotherapy In humans OGX-011 in combination with hormone therapy has been shown to decrease the tissue levels of a protein called clusterin which can be overproduced in cancer cells Clusterin has been found to block cell death and makes cells more resistant to cancer therapy Gemcitabine GEM cisplatin CIS and carboplatin CARB have been approved by Health Canada and the Food and Drug Administration in the United States for the treatment of patients with lung cancer
OGX-011 was administered as a 2-hr intravenous IV infusion on Days -7 -5 and -3 prior to Cycle 1 then weekly on Days 1 8 15 of each 21-day cycle GEM was infused IV after OGX-011 on Days 1 and 8 either CIS or CARB was infused IV after GEM on Day 1 of each cycle Six cycles of treatment were planned Most patients received OGX-011 at 640 mg but 3 patients received OGX-011 at 480 mg dose OGX-011 dose groups were combined due to the small number of patients who received 480 mg
OGX-011 was administered as a 2-hr intravenous IV infusion on Days -7 -5 and -3 prior to Cycle 1 then weekly on Days 1 8 15 of each 21-day cycle GEM was infused IV after OGX-011 on Days 1 and 8 either CIS or CARB was infused IV after GEM on Day 1 of each cycle Six cycles of treatment were planned Most patients received OGX-011 at 640 mg but 3 patients received OGX-011 at 480 mg dose OGX-011 dose groups were combined due to the small number of patients who received 480 mg
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