56
Participants
Start Date
October 3, 2022
Primary Completion Date
July 1, 2027
Study Completion Date
January 1, 2028
Lu-177-DOTATATE
Lu-177-DOTATATE will be given by IV every 8 (+/-2) weeks for a total of 4 administrations
Olaparib
Olaparib is given as a pill taken orally and is to be taken twice a day, starting from 2 days before the first administration of Lu-177-DOTATATE until 4 weeks after the last administration
Ga dotatate scanning
Ga68-DOTATATE PET/CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.
FDG-PET scanning
F18-FDG PET/CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.
Amino Acid infusion
Concomitant administration of an IV infusion of an amino acid (AA) solution will also be done for renal protection. The AA infusion will begin at least 30-60 minutes prior to injection of Lu-177-DOTATATE and will continue during and after the Lutathera infusion until the entire prescribed amount is infused.
RECRUITING
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH