Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03331250|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : January 30, 2018
This research study is studying a drug as a possible treatment for Angiosarcoma or Epithelioid hemangioendothelioma (EHE).
-The drug involved in this study is Eribulin
|Condition or disease||Intervention/treatment||Phase|
|Angiosarcoma Epithelioid Hemangioendothelioma||Drug: Eribulin||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved Eribulin for your specific disease but it has been approved for other uses.
In this research study, the investigators are studying how safe and effective eribulin is in participants with Angiosarcoma or EHE.
Eribulin was created to mimic the structure of a chemical that is released from a sea sponge. The investigators believe that this drug has anti-cancer effects on tumors by blocking proteins called microtubules, among other functions. It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die similar to other drugs that target microtubules
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase 2 Study of Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)|
|Actual Study Start Date :||January 18, 2018|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2025|
It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
Other Name: Halaven
- Objective Response Rate [ Time Frame: 2 years ]Partial response rate plus complete response rate by RECIST 1.1
- Progression Free Survival [ Time Frame: 4 years ]
- Disease Control Rate [ Time Frame: 24 weeks ]Objective Response plus Stable Disease Rate at 24 weeks
- Treatment Related Adverse Events [ Time Frame: 4 years ]Summary of the treatment related adverse events experienced by study participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
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): NCT03331250
|Contact: Barbara Anderson, RNfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Carol Gurski, RN 617-724-4000 CGURSKI@mgh.harvard.edu|
|Principal Investigator: Gregory M Cote, MD, PhD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Melissa Hohos, RN 617-632-3000|
|Principal Investigator: Katherine Thornton, MD|
|Principal Investigator:||Gregory Cote, MD, PhD||Massachusetts General Hospital|