Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors (NCT04750954)
A Phase 1b Trial of M3814 (Peposertib) in Combination With Lutetium 177 Dotatate for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
🩺 Plain-English Summary (8th-Grade Level)
This phase Ib trial is to find out the best dose, possible benefits and/or side effects of peposertib when given together with lutetium Lu 177 dotatate in treating patients with neuroendocrine tumors. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell formation, so as to help block the formation of growths that may become cancer. Radioactive drugs, such as lutetium Lu 177 dotatate, may deliver radiation directly to tumor cells and not harm normal cells. Adding peposertib to lutetium Lu 177 dotatate may kill more tumor cells.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (18 items).
Location: City of Hope Comprehensive Cancer Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients who have had major surgical procedures in the 4 weeks prior to enrollment
- Patients are excluded if they received prior systemic peptide receptor radionuclide therapy (PRRT)-based therapies
- Patients with an inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
- Patients who are receiving any other investigational agents
- Known brain metastases, unless these metastases have been treated and stabilized for at least 4 weeks, prior to enrollment in the study. Patients with a history of brain metastases must have either a head CT with contrast or brain MRI to document stable disease prior to enrollment in the study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to M3814 (peposertib) or lutetium Lu 177 dotatate
- Prior external beam radiotherapy to more than 50% of bone marrow (whole body) will be excluded, as determined by a radiation medicine physicist who will calculate the volume of bone marrow exposure in prior radiotherapy portals divided by the volume of total bone marrow harboring tissues. This ratio must be less than 50 percent
- Patients who cannot discontinue concomitant medications or herbal supplements that are strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzymes CYP3A4/5, CYP2C9, and CYP2C19. Concomitant use of CYP3A4/5, 1A2, 2B6, 2C8, substrates with a narrow therapeutic index are also excluded. Patients may confer with the study doctor to determine if alternative medications can be used. The following categories of medications and herbal supplements must be discontinued for at least the specified period of time before the patient can be treated:
- Strong inducers of CYP3A4/5, CYP2C9 and CYP2C19: \>= 3 weeks prior to study treatment
- Strong inhibitors of CYP3A4/5, CYP2C9 and CYP2C19: \>= 1 week prior to study treatment
- Substrates of CYP3A4/5, 1A2, 2B6, 2C8, with a narrow therapeutic index: \>= 1 day prior to study treatment Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- City of Hope Comprehensive Cancer Center — Duarte, California
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Neuroendocrine Neoplasm clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.