OncoMatch/Clinical Trials/NCT04086485
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)
Is NCT04086485 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Lu-177-DOTATATE and Olaparib for gastroenteropancreatico tumors.
Treatment: Lu-177-DOTATATE · Olaparib · Amino Acid infusion — Background: A neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors. Objective: To learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lutathera and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink. Eligibility: Adults 18 and older who have a neuroendocrine tumor in the pancreas or intestine that cannot be cured by surgery and has somatostatin receptors on the cells. Design: Eligible participants will get Lutathera through an intravenous (IV) infusion every 8 weeks for 4 cycles. One cycle is 8 weeks. Each cycle includes a follow-up visit at week 4. For the IV, a small plastic tube is put into an arm vein. Participants will also take Olaparib by mouth twice a day for 4 weeks of each cycle. They will use a medicine diary to track the doses. During the study, participants will have physical exams. They will have blood and urine tests. They will fill out questionnaires about their general well-being and function. Their heart function will be tested. They will have scans of their chest, abdomen, and pelvis. One type of scan will use an IV infusion of a radioactive tracer. Participants will have a follow-up visit about 4 weeks after treatment ends. Then they will have follow-up visits every 12 weeks for 3 years. Then they will have yearly phone calls....
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Radioligand therapy
Other
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: BRCA1 any tested
Known BRCA mutation status (Cohort 3 only).
Required: BRCA2 any tested
Known BRCA mutation status (Cohort 3 only).
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: somatostatin analogue (octreotide, lanreotide, sandostatin)
Patients on somatostatin analogue therapy (e.g., but not only limited to sandostatin or lanreotide therapy) must have initiated and been on a consistent dose of therapy for at least 3 months prior to study enrollment.
Cannot have received: PARP inhibitor (olaparib)
Any previous treatment with PARP inhibitor, including olaparib
Cannot have received: systemic radionuclide agent (Lu-177-DOTATATE)
Any previous treatment with any systemic radionuclide agents. Previous treatment with Lu-177-DOTATATE.
Cannot have received: allogeneic hematopoietic stem cell transplant
Previous allogeneic hematopoietic stem cell transplant, allogeneic bone marrow transplant or double umbilical cord blood transplant (duCBT).
Lab requirements
Blood counts
Hemoglobin >= 10.0 g/dL with no blood transfusion in past 28 days; ANC >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L
Kidney function
Creatinine clearance >= 51 mL/min (MDRD equation or 24 hour urine test)
Liver function
Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 2.5 x ULN unless liver metastases present, then <= 5x ULN
Patients must have normal organ and bone marrow function measured within 28 days prior to enrollment as defined below: Hemoglobin >= 10.0 g/dL with no blood transfusion in the past 28 days; Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; Total bilirubin <= 1.5 x institutional upper limit of normal (ULN); AST/ALT <= 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be <= 5x ULN; Creatinine clearance estimated of >= 51 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04086485 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PARP inhibitor, systemic radionuclide agent, allogeneic hematopoietic stem cell transplant disqualifies patients from enrollment.
Does this trial require BRCA1?
Yes, BRCA1 any tested is a required biomarker for enrollment.
Does this trial require BRCA2?
Yes, BRCA2 any tested is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 100 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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