This study will assess the long-term safety and efficacy of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
Individual participation in this study will last approximately 48 months for participants who received AAV2-hAQP1 in Study MGT-AQP1-201 and at least 60 months for participants who receive AAV2-hAQP1 in Study MGT-AQP1-202.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States
University of Iowa
Iowa City, Iowa, United States
University of Missouri
Columbia, Missouri, United States
Number of participants with study drug-related adverse events and serious adverse events
Time frame: From study start until Month 60 post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Erie County Medical Center
Buffalo, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States
Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North
Greater Sudbury, Ontario, Canada