Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

October 3, 2022

Primary Completion Date

July 1, 2027

Study Completion Date

January 1, 2028

Conditions
Gastroenteropancreatico TumorsNeuroendocrine TumorsNeuroendocrine Neoplasms
Interventions
DRUG

Lu-177-DOTATATE

Lu-177-DOTATATE will be given by IV every 8 (+/-2) weeks for a total of 4 administrations

DRUG

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

DIAGNOSTIC_TEST

Ga dotatate scanning

Ga68-DOTATATE PET/CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.

DIAGNOSTIC_TEST

FDG-PET scanning

F18-FDG PET/CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.

DRUG

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.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH