A Phase II Study of BVD-523 in Metastatic Uveal Melanoma
|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: NCT03417739|
Recruitment Status : Active, not recruiting
First Posted : January 31, 2018
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma||Drug: BVD-523||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 BVD-523 as a treatment for any disease.
BVD-523 has been tested in patients with solid tumors to determine the highest dose of BVD-523 that can be safely given to patients.
In this research study, the investigators are evaluating the role of BVD-523 in the treatment of patients with uveal melanoma. Genetic changes within metastatic uveal melanoma activate proteins in the MAPK protein signaling pathway which leads to tumor growth. In the laboratory BVD-523 works against one of these proteins called ERK to decrease tumor growth. In this study, the investigators are testing BVD-523 to see if it works to treat metastatic uveal melanoma.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of BVD-523 in Metastatic Uveal Melanoma|
|Actual Study Start Date :||March 26, 2018|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2025|
BVD-523 is to be taken twice daily orally for 28 consecutive days
In the laboratory BVD-523 works against proteins called ERK to decrease tumor growth
- Overall Response Rate [ Time Frame: 3 months - 2 years ]Tumor measurement by CT or other imaging method at initial imaging and subsequent imaging with responses graded by RECIST criteria.
- Overall Survival [ Time Frame: 2 years ]The time from study enrollment until death.
- Disease Control Rate [ Time Frame: 3 months - 2 years ]A combination of patients who experience complete response, partial response and stable disease on CT or other form of imaging
- Time to Tumor Progression [ Time Frame: 2 years ]Time from enrollment on study until the tumor is progressing by RECIST criteria
- Duration of Response Rate [ Time Frame: 2 years ]Time when initial complete response or partial response is initially recorded until the first date that recurrent or progressive disease is documented.
- Incidence of treatment associated adverse events [ Time Frame: 2 years ]Monitoring for adverse events and severe adverse events associated with study therapy.
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): NCT03417739
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Elizabeth Buchbinder, MD||Dana-Farber Cancer Institute|