Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT01196234
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2010-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study
Status:
COMPLETED
Status Verified Date:
2013-01
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:
PRIDE
Brief Summary:
This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations.
Expanded acronym : \[P\]aclitaxel/Ca\[r\]boplatin (PC) followed by Gef\[i\]tinib in A\[d\]vanc\[e\]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.
Expanded acronym : \[P\]aclitaxel/Ca\[r\]boplatin (PC) followed by Gef\[i\]tinib in A\[d\]vanc\[e\]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.
Detailed Description:
A randomized phase II trial that compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with NSCLC without EGFR mutations. While previous studies with cytotoxic agents and gefitinib failed to show any benefit, we altered the schedule of administration in hopes to gain synergy between agents.
Study Oversight
Has Oversight DMC:
False
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?: