A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02795858|
Recruitment Status : Active, not recruiting
First Posted : June 10, 2016
Last Update Posted : April 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoid Tumors||Drug: Ramucirumab Drug: Somatostatin Analog||Phase 2|
This research study is a Phase II clinical trial. The purpose of this study is to test the safety and effectiveness of ramucirumab in advanced, progressive carcinoid tumors.
Cancer cells can make growth factors that cause the abnormal growth of new blood vessels. Ramucirumab is an investigational drug which works by blocking a receptor for a vascular growth factor, thereby preventing new blood vessels from forming. This may stop the cancer from growing or spreading and the tumor cells may die.
The FDA (the U.S. Food and Drug Administration) has not approved Ramucirumab for treatment of Carcinoid Tumors.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors|
|Actual Study Start Date :||June 14, 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2023|
Experimental: Ramucirumab In Combination With Somatostatin Analog
Patients will receive treatment with Ramucirumab at a pre-determined dose intravenously every 14 days of a 28-day treatment cycle.
Patients will receive treatment with a Somatostatin Analog at a pre-determined dose.
Toxicity and adverse events will be examined in the first 10 patients who complete one cycle of therapy before expanding enrollment.
Other Name: Cyramza
Drug: Somatostatin Analog
- Progression Free Survival Duration [ Time Frame: 2 years ]
- Number of Participants with Adverse Event [ Time Frame: 2 years ]
- Overall Survival Rate [ Time Frame: 2 years ]
- Overall Radiographic And Biochemical Response Rate [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795858
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jennifer A Chan, MD MPH||Dana-Farber Cancer Institute|