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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of cycle 1
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am 18 years old or older.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at disease progression
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at disease progression
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Maximum Tolerated Dose
Phase 2: Overall Response Rate
Secondary outcome measures
Phase 1: BOR and PFS
Phase 2: PFS and OS
Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
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%
Hyperglycaemia
9%
Aspartate aminotransferase increased
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
~2140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,863 Total Patients Enrolled
78 Trials studying Neuroendocrine Tumors
43,581 Patients Enrolled for Neuroendocrine Tumors
Frank I Lin, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
90 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or radiotherapy in the last 4 weeks.I do not have any unmanaged ongoing illnesses.I have brain metastases that are causing symptoms and are not under control.I am fully active and can carry on all my pre-disease activities without restriction.My GEP-NET lesions don't show on Ga-68-DOTATATE-PET but do on FDG-PET, and I've had at least one treatment.I have been treated with PARP inhibitors or radionuclide agents before.My cancer has grown or spread in the last 3 years, and there's at least one tumor that can be measured.I have lasting side effects from cancer treatment that are moderate or worse.I have been treated with Lu-177-DOTATATE before.I have no other cancers except for non-dangerous skin cancer or treated cervical cancer with no signs of return in 5 years.My spinal cord compression has been definitively treated.I have been on a stable dose of somatostatin analogue therapy for at least 3 months.I am 18 years old or older.My cancer shows positive for somatostatin receptors on a recent PET scan.My organ and bone marrow functions are normal.I haven't taken strong or moderate CYP3A inhibitors in the last 2 weeks.I have an active hepatitis B or C infection.I have been diagnosed with a neuroendocrine tumor.I have had a stem cell or bone marrow transplant from a donor.I cannot take medicine by mouth.My condition cannot be treated with surgery due to its advanced stage.I haven't taken strong or moderate drugs that affect liver enzymes recently.I can stop my octreotide treatment for 24 hours for the Lu-177-DOTATATE therapy.I have not had major surgery in the last 4 weeks.I have been diagnosed with a blood disorder that could be or is turning into leukemia.I have at least one cancer lesion that has not been treated with radiation.
Research Study Groups:
This trial has the following groups:- Group 1: 2/Lu-177-DOTATATE + Olaparib fixed dose
- Group 2: 1/Lu-177-DOTATATE + Olaparib escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the enrollment requirements currently open for this research project?
"Per clinicaltrials.gov, this medical study is still in the midst of participant recruitment. The initial advertisement was posted on October 3rd 2022 with a subsequent update issued 10 days later on October 13th."
Answered by AI
Is this investigation an original endeavor?
"At present, 227 trials involving Olaparib are actively taking place in 1484 cities across 59 countries. This drug initially entered a Phase 1 clinical trial back in 2005 and was backed by AstraZeneca. The initial study included 98 participants who successfully completed the testing procedure. Since then, 73 more studies have been conducted with this medication."
Answered by AI
How many individuals are being evaluated as part of this investigation?
"Affirmative. The facts on clinicaltrials.gov demonstrate that this research study, which was initially publicised on October 3rd 2022 is actively recruiting participants. A total of 37 individuals are required for the trial at one facility."
Answered by AI
For what purposes is Olaparib typically prescribed?
"Olaparib is the most common medication for treating advance directives. This drug can also provide relief from neoplasms, malignant ovarian tumours, and primary peritoneal cancer."
Answered by AI
Have any other trials been conducted using Olaparib?
"Presently, 227 clinical trials are actively investigating the efficacy of Olaparib with 30 being in phase 3. This medication is available for research at over 9500 centres, many of which situated in Houston, Texas."
Answered by AI
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