Ignite Creation Date:
2024-05-06 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03639467
Status:
UNKNOWN
Last Update Posted:
2018-09-18
First Post:
2018-08-15
Brief Title:
Study of Anlotinib Combined With GemcitabineCisplatin in Advanced Nasopharyngeal Carcinoma
Sponsor:
Chinese Academy of Medical Sciences
Organization:
ChineseAMS
Study Overview
Official Title:
Phase Ib II Study of Anlotinib Combined With GemcitabineCisplatin in Previous Untreated Patients With RecurrentMetastatic Nasopharyngeal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
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:
Gemcitabine plus cisplatin GC is more effective than fluorouracil plus cisplatin in the treatment of recurrent or metastatic NPC RM-NPC GC is the standard first-line chemotherapy regimen for this population However the median progression-free survival was only 7 months for GC regimen Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets especially for VEGFR2VEGFR3PDGFRβ and c-Kit which has strong effect of anti-angiogenesis This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus GC as first-line treatment for RM-NPC
Detailed Description:
In the phase Ib portion an escalated dose cohort is recruited to determine the maximum tolerated dose MTD and recommended phase II dose RP2D of anlotinib when given in combination with gemcitabinecisplatin The phase II portion is designed to characterize the efficacy and safety of the combination therapy in previous untreated patients with RM-NPC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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