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Radioisotope Therapy

Lutathera + Olaparib for Neuroendocrine Cancer

Phase 1 & 2
Recruiting
Led By Frank I Lin, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status of <=1
Patients on somatostatin analogue therapy must have initiated and been on a consistent dose of therapy for at least 3 months prior to study enrollment
Must not have
Uncontrolled inter-current illness
Symptomatic, uncontrolled brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of cycle 1
Awards & highlights

Summary

This trial is testing if a combination of 2 drugs can help people with neuroendocrine tumors by making the tumors shrink without having severe side effects.

Who is the study for?
Adults over 18 with inoperable neuroendocrine tumors in the pancreas or intestine, which have somatostatin receptors and haven't been cured by surgery. Participants must not be pregnant, agree to use contraception, and should not have had certain previous cancer treatments or uncontrolled illnesses.
What is being tested?
The trial is testing if Lutathera (given via IV every 8 weeks for four cycles) combined with Olaparib (taken orally twice daily for four weeks each cycle) can safely shrink gastroenteropancreatic neuroendocrine tumors without causing severe side effects.
What are the potential side effects?
Possible side effects include nausea, fatigue, blood count changes leading to increased infection risk, kidney damage from the radioactive tracer used in scans, and allergic reactions to either drug. Specific side effect experiences may vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all my pre-disease activities without restriction.
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I have been on a stable dose of somatostatin analogue therapy for at least 3 months.
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I am 18 years old or older.
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My organ and bone marrow functions are normal.
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I have been diagnosed with a neuroendocrine tumor.
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My condition cannot be treated with surgery due to its advanced stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any unmanaged ongoing illnesses.
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I have brain metastases that are causing symptoms and are not under control.
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I have been treated with PARP inhibitors or radionuclide agents before.
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I have lasting side effects from cancer treatment that are moderate or worse.
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I have been treated with Lu-177-DOTATATE before.
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My spinal cord compression has been definitively treated.
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I have an active hepatitis B or C infection.
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I have had a stem cell or bone marrow transplant from a donor.
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I cannot take medicine by mouth.
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I have not had major surgery in the last 4 weeks.
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I have been diagnosed with a blood disorder that could be or is turning into leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at disease progression
This trial's timeline: 3 weeks for screening, Varies for treatment, and at disease progression for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Maximum Tolerated Dose
Phase 2: Overall Response Rate
Secondary study objectives
Phase 1: BOR and PFS
Phase 2: PFS and OS

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Lu-177-DOTATATE + Olaparib fixed doseExperimental Treatment5 Interventions
Lu-177-DOTATATE and olaparib at the MTD
Group II: 1/Lu-177-DOTATATE + Olaparib escalationExperimental Treatment5 Interventions
Lu-177-DOTATATE and escalating doses of olaparib to determine the maximum-tolerated dose (MTD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,958 Total Patients Enrolled
81 Trials studying Neuroendocrine Tumors
43,676 Patients Enrolled for Neuroendocrine Tumors
Frank I Lin, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
263 Total Patients Enrolled
3 Trials studying Neuroendocrine Tumors
263 Patients Enrolled for Neuroendocrine Tumors

Media Library

Lu-177-DOTATATE (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04086485 — Phase 1 & 2
Neuroendocrine Tumors Research Study Groups: 2/Lu-177-DOTATATE + Olaparib fixed dose, 1/Lu-177-DOTATATE + Olaparib escalation
Neuroendocrine Tumors Clinical Trial 2023: Lu-177-DOTATATE Highlights & Side Effects. Trial Name: NCT04086485 — Phase 1 & 2
Lu-177-DOTATATE (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04086485 — Phase 1 & 2
~12 spots leftby Jul 2025
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