Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)
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|ClinicalTrials.gov Identifier: NCT03331250|
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : March 20, 2023
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)|
|Actual Enrollment :||13 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|
|Actual Primary Completion Date :||July 21, 2022|
|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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Gregory Cote, MD, PhD||Massachusetts General Hospital|