Ignite Creation Date:
2024-05-06 @ 12:38 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03818997
Status:
WITHDRAWN
Last Update Posted:
2020-02-05
First Post:
2019-01-24
Brief Title:
Combination of Targeted and Immunotherapy for Advanced Biliary Tract and Esophagogastric Gastric Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
DKN-01Atezolizumab as Second Line Treatment of biliarY Tract Cancer and in combiNAtion or Not With Paclitaxel as Second Line treatMent of esophagogastrIC Cancer a Multi-center Phase II Trial
Status:
WITHDRAWN
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DYNAMIC
Brief Summary:
In this study non-operable esophagogastric adenocarcinoma cancer patients or non-operable biliary cancer patients whose cancer progressedspreadgot worse after first line treatment will be treated with or without immunotherapy and chemotherapy This study will take place in several countries across Europe One hundred twenty-three 123 patients will be invited to participate in this study
Biliary tract cancer BTC is a form of cancer that start in your bile ducts a series of tubes that runs from the liver to the small intestines It is not know yet the exact cause of BTC For patients who have advanced or metastatic BTC where surgery is not possible chemotherapy is the first option for treatment Chemotherapy with cisplatin and gemcitabine CisGem is the current standard of care
Esophagogastric cancer EGC is cancer that occurs in the esophagus a long hollow tube that runs from your throat to your stomach The accumulating abnormal cells form a tumor in the esophagus that can grow to invade nearby structures and spread to other parts of the body Its thought that chronic irritation of your esophagus may contribute to the changes that cause esophageal cancer
The purpose of this study is to look at the risks and benefits of combining DKN-01 and atezolizumab humanized monoclonal antibody with or without paclitaxel chemotherapy Immune therapy boosts the bodys natural defenses to fight cancer It uses specific products made either by participants body or in a laboratory to improve target or restore immune system function and control or stop cancer Atezolizumab is such an immunotherapy drug DKN-01 is another new type of drug humanized monoclonal antibody in development as anticancer agent Paclitaxel is a commonly-used chemotherapy drug of the class of taxanes used to treat a number of cancer types it stimulates the cell to die or to stop the cell from dividing into two new cellsThe idea behind combining these drugs is linked to targeting the immune system to attack the tumor Combining immune and chemotherapy has already demonstrated clinical activity in relapsed return of the diseaserefractory not responding to treatment esophagogastric cancer patients
Biliary tract cancer BTC is a form of cancer that start in your bile ducts a series of tubes that runs from the liver to the small intestines It is not know yet the exact cause of BTC For patients who have advanced or metastatic BTC where surgery is not possible chemotherapy is the first option for treatment Chemotherapy with cisplatin and gemcitabine CisGem is the current standard of care
Esophagogastric cancer EGC is cancer that occurs in the esophagus a long hollow tube that runs from your throat to your stomach The accumulating abnormal cells form a tumor in the esophagus that can grow to invade nearby structures and spread to other parts of the body Its thought that chronic irritation of your esophagus may contribute to the changes that cause esophageal cancer
The purpose of this study is to look at the risks and benefits of combining DKN-01 and atezolizumab humanized monoclonal antibody with or without paclitaxel chemotherapy Immune therapy boosts the bodys natural defenses to fight cancer It uses specific products made either by participants body or in a laboratory to improve target or restore immune system function and control or stop cancer Atezolizumab is such an immunotherapy drug DKN-01 is another new type of drug humanized monoclonal antibody in development as anticancer agent Paclitaxel is a commonly-used chemotherapy drug of the class of taxanes used to treat a number of cancer types it stimulates the cell to die or to stop the cell from dividing into two new cellsThe idea behind combining these drugs is linked to targeting the immune system to attack the tumor Combining immune and chemotherapy has already demonstrated clinical activity in relapsed return of the diseaserefractory not responding to treatment esophagogastric cancer patients
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None