Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03611738
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2018-07-27
Brief Title:
Ceritinib Plus Docetaxel in ALK-Negative EGFR WT Advanced NSCLC
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase I Study of Ceritinib Plus Docetaxel in ALK-Negative EGFR WT Advanced NSCLC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to find out what effects good and bad ceritinib Zykadia used in combination with docetaxel Taxotere will have on participants and their cancer The results will help to determine the best safe dose of the combination of the medications Ceritinib Zykadia and docetaxel Taxotere and to find out if this combination of drugs will help people that have this type of Non-small Cell Lung Cancer NSCLC
Detailed Description:
In this phase IIB clinical trial participants with non-small cell lung cancer NSCLC who have progressed on prior platinum-based chemotherapy maximum number of prior distinct regimens 2 and are anaplastic lymphoma kinase ALK-negativeepidermal growth factor receptor EGFR wild-type WT will receive a combination of ceritinib and docetaxel
Study rationale is that targeting ALK- and EGFR-negative lung tumors with ceritinib and microtubule inhibitors results in synergistic antitumor effects Therefore treatment with ceritinib and docetaxel is a rational combination
Study rationale is that targeting ALK- and EGFR-negative lung tumors with ceritinib and microtubule inhibitors results in synergistic antitumor effects Therefore treatment with ceritinib and docetaxel is a rational combination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None