Who is eligible for clinical trial NCT04172532?

Participants must meet the protocol's inclusion criteria for Locally Advanced Pancreatic Adenocarcinoma. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04172532 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer (NCT04172532)

A Phase 1/2 Study of M3814 (Peposertib) in Combination With Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma

RECRUITING Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

🩺 Plain-English Summary (8th-Grade Level)

This phase I/II trial studies the safety, side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving M3814 and hypofractionated radiation therapy together may be safe, tolerable and/or more effective than radiation therapy alone in treating patients with locally advanced pancreatic cancer.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (30 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

Peposertib (DRUG)

Check 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:

Patients who have completed induction chemotherapy less than 2 weeks or more than 8 weeks prior to study enrollment
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and neuropathy grade =\< 2
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to M3814 (peposertib)
Evidence of distant metastatic disease
More than 1 line of chemotherapy for the treatment of localized pancreatic cancer, unless the change in treatment was made only for toxicity
Prior abdominal radiation
Active inflammatory bowel disease or connective tissue disease
Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
History of anaphylactic reaction to iodinated intravenous (IV) contrast required for radiation simulation. Patients with mild reactions may be enrolled, but must receive premedications for contrast allergy prior to imaging
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 substrates with a narrow therapeutic index that are metabolized by CYP1A2, CYP2B6, CYP2C8, and CYP3A4/5 are also excluded.
Use caution with other substrates of CYP3A4/5, CYP1A2, CYP2B6, CYP2C8 and substrates of P-gp, BCRP, OCT1, OAT3, OATP1B1, OATP1B3, MATE1, and MATE-2K with a narrow therapeutic index. Close monitoring is advised. 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. (Patient Drug Interactions Handout and Wallet Card) should be provided to patients

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (44 Sites)

Showing the first 25 of 44 sites.

City of Hope Comprehensive Cancer Center — Duarte, California
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
City of Hope at Irvine Lennar — Irvine, California
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
University of California Davis Comprehensive Cancer Center — Sacramento, California
UCHealth University of Colorado Hospital — Aurora, Colorado
Sibley Memorial Hospital — Washington D.C., District of Columbia
Northwestern University — Chicago, Illinois
University of Kansas Clinical Research Center — Fairway, Kansas
HaysMed — Hays, Kansas
University of Kansas Cancer Center — Kansas City, Kansas
Lawrence Memorial Hospital — Lawrence, Kansas
The University of Kansas Cancer Center - Olathe — Olathe, Kansas
University of Kansas Cancer Center-Overland Park — Overland Park, Kansas
Mercy Hospital Pittsburg — Pittsburg, Kansas
Salina Regional Health Center — Salina, Kansas
University of Kansas Health System Saint Francis Campus — Topeka, Kansas
University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
University of Kentucky/Markey Cancer Center — Lexington, Kentucky
Wayne State University/Karmanos Cancer Institute — Detroit, Michigan
Weisberg Cancer Treatment Center — Farmington Hills, Michigan
University Health Truman Medical Center — Kansas City, Missouri
University of Kansas Cancer Center - North — Kansas City, Missouri
University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri
University of Kansas Cancer Center at North Kansas City Hospital — North Kansas City, Missouri

📞 Contact the Study Coordinator

Phone: (800) 826-4673

Email: becomingapatient@coh.org

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.

💡 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.

🏛️ View Official NIH Record ↗