Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073723
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2003-12-03
Brief Title:
Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Celgene Corporation
Organization:
Celgene Corporation
Study Overview
Official Title:
An Open-label Phase III Trial of ABI-007 A Cremophor EL-Free Protein Stabilized Nanoparticle Paclitaxel Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 anticancer agent paclitaxel Taxol for Injection Concentrate Bristol-Meyers Squibb has a broad spectrum of activity against several human cancers including carcinomas of ovary breast lung esophagus and head and neck cancer Taxol has shown remarkable activity against metastatic breast cancer yielding response rates in the range of 40 to 60 in chemotherapy-naive patients and 25-30 in patients refractory to anthracycline-containing regimens Taxol package insert The major limitation of Taxol is its poor water soluability requiring Cremophor containing castor oil and ethanol as a solvent Taxol in this vehicle must be administered over 3-24 hours and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid an antihistamine and an H2 antagonist
Detailed Description:
ABI-007 a unique protein formulation of paclitaxel has been developed to reduce the toxicities associated with Taxol and Cremophor ELethanol vehicle while maintaining or improving the chemotherapeutic effect of the drug
The activity of ABI-007 in other malignancies is not yet well established This open-label Phase III study is being conducted to define the maximum tolerated dose MTD and dose-limiting toxicities DLT of ABI-007 and evaluate the safety and antitumor activity of ABI-007 in patients with advanced Stage IV non-small cell lung cancer NSCLC
The activity of ABI-007 in other malignancies is not yet well established This open-label Phase III study is being conducted to define the maximum tolerated dose MTD and dose-limiting toxicities DLT of ABI-007 and evaluate the safety and antitumor activity of ABI-007 in patients with advanced Stage IV non-small cell lung cancer NSCLC
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