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Radioactive Drug

Peposertib + Radiation Therapy for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Lowell Anthony
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
Age >= 18 years
Failure of at least one prior systemic cancer treatment with somatostatin analogs
Must not have
Discontinue long-acting somatostatin analogs for at least 4 weeks prior to initiating lutetium Lu 177 dotatate
Patients with an inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the combination of peposertib and lutetium Lu 177 dotatate in patients with neuroendocrine tumors. Peposertib blocks enzymes needed for tumor growth, while lutetium Lu 177 dotatate targets and kills tumor cells with radiation. Lutetium Lu 177 dotatate has been used to treat inoperable neuroendocrine tumors and has shown to improve patients' quality of life. The goal is to find the best dose and observe potential benefits and side effects.

Who is the study for?
Adults with well-differentiated pancreatic neuroendocrine tumors, who've had a positive dotatate scan and failed at least one cancer treatment. They must have good organ function, no prior radionuclide therapy, be able to swallow pills, not pregnant or breastfeeding, and without serious infections or psychiatric issues that could affect participation.
What is being tested?
The trial is testing the combination of M3814 (Peposertib) with Lutetium Lu 177 Dotatate radiation therapy to determine the best dose and assess potential benefits and side effects in treating neuroendocrine tumors. Peposertib blocks enzymes needed for cell growth while the radioactive drug targets tumor cells.
What are the potential side effects?
Possible side effects include reactions related to blocking cell growth enzymes by peposertib which might affect normal cellular functions, as well as radiation-related effects from Lutetium Lu 177 Dotatate that may cause damage to both tumor and potentially some normal cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have tried a cancer treatment involving somatostatin analogs without success.
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I have never had peptide receptor radionuclide therapy.
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I have chronic hepatitis B but it's under control with medication.
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I will avoid pregnancy or fathering a child for the required period after my last lutetium treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I had hepatitis C but am now cured or currently being treated with an undetectable viral load.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have stopped taking long-acting somatostatin analogs for 4 weeks.
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I cannot swallow pills or have a condition that affects how my body absorbs medication.
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I have not had major surgery in the last 4 weeks.
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I have received PRRT-based treatments before.
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I have not had a live vaccine or an active infection in the last 4 weeks.
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I do not have any unmanaged ongoing illnesses.
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I am allergic to certain cancer drugs similar to M3814 or lutetium Lu 177 dotatate.
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I cannot stop taking my acid reflux medication.
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I have had extensive radiation therapy affecting most of my bone marrow.
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I cannot stop taking certain medications or supplements that affect my liver enzymes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicity
Secondary study objectives
Overall response rate
Overall survival
Progression free survival
Other study objectives
Krenning score from the gallium 68 or copper 64 dotatate
Pharmacokinetic (PK) analysis
Radiographic expression of somatostatin receptors

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (peposertib, lutetium Lu 177 dotatate)Experimental Treatment5 Interventions
Patients receive peposertib PO QD or BID on days 1-21 and lutetium Lu 177 dotatate IV over 30 minutes on day 1. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI throughout the trial and undergo collection of blood samples on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2790
Biospecimen Collection
2004
Completed Phase 3
~2030
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Peposertib
2021
Completed Phase 1
~20

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neuroendocrine Tumors (NETs) are often treated using targeted therapies that exploit specific characteristics of the tumor cells. Lutetium Lu 177 Dotatate is a form of peptide receptor radionuclide therapy (PRRT) that delivers targeted radiation to tumor cells expressing somatostatin receptors, thereby minimizing damage to surrounding healthy tissue. This targeted approach is crucial for reducing side effects and improving treatment efficacy. Peposertib, an enzyme inhibitor, works by blocking enzymes necessary for tumor cell growth and survival, thereby inhibiting tumor progression. Combining these therapies can potentially enhance treatment outcomes by simultaneously attacking the tumor through different mechanisms, offering a more comprehensive approach to managing NETs.
Outcome and toxicity of salvage therapy with 177Lu-octreotate in patients with metastatic gastroenteropancreatic neuroendocrine tumours.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,159 Total Patients Enrolled
81 Trials studying Neuroendocrine Tumors
43,744 Patients Enrolled for Neuroendocrine Tumors
Lowell AnthonyPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
10 Patients Enrolled for Neuroendocrine Tumors
Aman ChauhanPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
2 Previous Clinical Trials
123 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
123 Patients Enrolled for Neuroendocrine Tumors

Media Library

Lutetium Lu 177 Dotatate (Radioactive Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04750954 — Phase 1
Neuroendocrine Tumors Research Study Groups: Treatment (peposertib, lutetium Lu 177 dotatate)
Neuroendocrine Tumors Clinical Trial 2023: Lutetium Lu 177 Dotatate Highlights & Side Effects. Trial Name: NCT04750954 — Phase 1
Lutetium Lu 177 Dotatate (Radioactive Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04750954 — Phase 1
~7 spots leftby Dec 2025