Study: NCT03972488

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lutathera
Description: Lutathera is a sterile radiopharmaceutical supplied as a ready-to-use solution for infusion containing 177Lu-DOTA0-Tyr3-octreotate as a drug substance with a volumetric activity of 370 MBq/mL at reference date and time (calibration time). Each Lutathera infusion continued for 30 min.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lutathera
Description: Lutathera is a sterile radiopharmaceutical supplied as a ready-to-use solution for infusion containing 177Lu-DOTA0-Tyr3-octreotate as a drug substance with a volumetric activity of 370 MBq/mL at reference date and time (calibration time). Each Lutathera infusion continued for 30 min.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lutathera
Description: Lutathera is a sterile radiopharmaceutical supplied as a ready-to-use solution for infusion containing 177Lu-DOTA0-Tyr3-octreotate as a drug substance with a volumetric activity of 370 MBq/mL at reference date and time (calibration time). Each Lutathera infusion continued for 30 min.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lutathera
Description: Lutathera is a sterile radiopharmaceutical supplied as a ready-to-use solution for infusion containing 177Lu-DOTA0-Tyr3-octreotate as a drug substance with a volumetric activity of 370 MBq/mL at reference date and time (calibration time). Each Lutathera infusion continued for 30 min.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot)
Description: Sandostatin® LAR Depot (octreotide LAR) is a pharmaceutical that was available in single-use kits containing a 6-mL vial of 10 mg, 20 mg, or 30 mg strength for intramuscular injection, a syringe containing 2.5 mL of diluent, two sterile 1½ 19-gauge needles, and two alcohol wipes.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 2.5% Lys-Arg sterile amino acid solution
Description: Participants who received Lutathera were administered a concomitant 2.5% Lys-Arg solution for kidney protection, with each Lutathera dose. The 2.5% Lys-Arg solution was administered intravenously for 4 hours (infusion rate: 250 ml/h); the infusion was to start 30 minutes prior to the start of the Lutathera infusion and continue during (30 min) and up to at least 3 hours after the Lutathera infusion.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: High dose 60 mg octreotide long-acting repeatable
Description: Sandostatin® LAR Depot (octreotide LAR) is a pharmaceutical that was available in single-use kits containing a 6-mL vial of 10 mg, 20 mg, or 30 mg strength for intramuscular injection, a syringe containing 2.5 mL of diluent, two sterile 1½ 19-gauge needles, and two alcohol wipes.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: High dose 60 mg octreotide long-acting repeatable
Description: Sandostatin® LAR Depot (octreotide LAR) is a pharmaceutical that was available in single-use kits containing a 6-mL vial of 10 mg, 20 mg, or 30 mg strength for intramuscular injection, a syringe containing 2.5 mL of diluent, two sterile 1½ 19-gauge needles, and two alcohol wipes.