Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076609
Status:
COMPLETED
Last Update Posted:
2007-03-28
First Post:
2004-01-27
Brief Title:
Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
Sponsor:
PhytoCeutica
Organization:
PhytoCeutica
Study Overview
Official Title:
A Phase III Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2007-03
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:
Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal cancers The advantages of capecitabine are that 1 it is an oral drug and 2 it is less toxic than many other chemotherapeutics In an off-label hepatocellular carcinoma HCC clinical study the response rate with capecitabine was 13 The botanical drug PHY906--currently manufactured pursuant to GMP standards and regulations--has been used in China for over 1800 years to treat gastrointestinal-related ailments Recently preclinical studies demonstrated that PHY906 potentiates the anti-tumor effect of capecitabine This trial will evaluate the safety and efficacy of PHY906 in enhancing the anti-tumor effects of capecitabine
Detailed Description:
None
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