Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411762
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2006-12-13
Brief Title:
A Phase III Multi-Center Open-Label Dose-Escalation Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Phase III Multi-Center Open-Label Dose-Escalation Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-03
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 aim of this research project is to determine the amount of capecitabine Xeloda which can be given safely with PHY906 investigational drug on a novel schedule It is also the aim of this research project to determine what the effects good andor bad are of combining capecitabine Xeloda with PHY906 investigational drug in the treatment of advanced pancreatic cancer
PHY906 is a powder from plants sold as a health food supplement in the United States PHY906 has been used in China Taiwan and other Asian countries as traditional Chinese medicine for hundreds of years
The other drug involved in this study capecitabine is an oral form of chemotherapy already approved by FDA in the management of colorectal and breast cancer
Laboratory studies in animal models have shown that the combination of capecitabine and PHY906 shrinks liver cancer and a pilot clinical study is currently evaluating this combination in patients with liver cancer to define the benefit PHY906 has also shown to decrease diarrhea related to chemotherapy in a small study performed in patients with colon cancer treated at the Yale Cancer Center Our recent laboratory studies have also shown that the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models This prompted us to test the combination of capecitabine and PHY906 in patients with advanced pancreatic cancer to assess the benefit in survival as well as any decrease in side effects such as diarrhea caused by capecitabine
PHY906 is a powder from plants sold as a health food supplement in the United States PHY906 has been used in China Taiwan and other Asian countries as traditional Chinese medicine for hundreds of years
The other drug involved in this study capecitabine is an oral form of chemotherapy already approved by FDA in the management of colorectal and breast cancer
Laboratory studies in animal models have shown that the combination of capecitabine and PHY906 shrinks liver cancer and a pilot clinical study is currently evaluating this combination in patients with liver cancer to define the benefit PHY906 has also shown to decrease diarrhea related to chemotherapy in a small study performed in patients with colon cancer treated at the Yale Cancer Center Our recent laboratory studies have also shown that the combination of capecitabine and PHY906 also shrink pancreatic tumors in mouse models This prompted us to test the combination of capecitabine and PHY906 in patients with advanced pancreatic cancer to assess the benefit in survival as well as any decrease in side effects such as diarrhea caused by 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