Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 6, 2017

Primary Completion Date

February 22, 2022

Study Completion Date

February 22, 2022

Conditions
Neuroendocrine Tumors
Interventions
DRUG

Satoreotide tetraxetan

Satoreotide tetraxetan administered in 3 cycles at intervals of 8 weeks (+ up to 2 additional optional cycles)

OTHER

Amino acid solution

"Given as an auxiliary product the day of the IMP infusion for safety reasons to protect the renal function.~Centres can use their established amino acid infusion or Ipsen amino acid solution (auxiliary medical product OPS301)"

OTHER

Antiemetic

To counteract the known side effects of the amino acid infusion, such as nausea, dexamethasone (antiemetic) and as-required ondansetron will be administered 15 to 30 minutes before the start of the amino acid infusion (unless there are contraindications for these drugs).

Trial Locations (9)

1090

University Hospital Vienna, Department of Nuclear Medicine, Vienna

3002

Peter MacCallum Cancer Centre, Molecular Imaging and Targeted Therapeutics Laboratory, East Melbourne

4031

University Hospital Basel, Department of Nuclear Medicine, Basel

6009

Ramsay Hollywood Private Hospital, Department of Nuclear Medicine, Perth

8000

University Hospital Aarhus, Department of Hepatology and Gastroenterology, Aarhus

44093

CHU de Nantes, Hotel Dieu, Service de Medecine Nucleaire, Nantes

77030

MD Anderson Cancer Center, Department of Nuclear Medicine, Houston

G1R2J6

CHU de Quebec - Universite Laval Research Center, Department of Radiology and Nuclear Medicine, Québec

NW3 2QG

Royal Free Hospital, Department of Nuclear Medicine, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY

NCT02592707 - Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs | Biotech Hunter | Biotech Hunter