Peposertib + Radiation Therapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Lowell Anthony, MD, FACP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Platelets >= 75,000/mcL

I am 18 years old or older.

I have a heart condition and have been assessed using the NYHA classification.

Exclusion Criteria

I have stopped taking long-acting somatostatin analogs for 4 weeks.

Patients receiving any other investigational agents

I cannot swallow pills or have a condition that affects how my body absorbs medication.

Treatment Details

Interventions

• Lutetium Lu 177 Dotatate (Radioactive Drug)
• Peposertib (ATR Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Treatment (peposertib, lutetium Lu 177 dotatate) Experimental Treatment 5 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.

Lutetium Lu 177 Dotatate is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Lutathera for:

• Gastroenteropancreatic neuroendocrine tumors

🇺🇸 Approved in United States as Lutathera for:

• Gastroenteropancreatic neuroendocrine tumors

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

City of Hope Comprehensive Cancer Center Duarte, CA

University of Kentucky/Markey Cancer Center Lexington, KY

Ohio State University Comprehensive Cancer Center Columbus, OH

Huntsman Cancer Institute/University of Utah Salt Lake City, UT

More Trial Locations

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References