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New treatment option for Locally Advanced Pancreatic Adenocarcinoma
Official title Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT04172532
What this study is testing
What is Peposertib?
Peposertib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for locally advanced pancreatic adenocarcinoma.
Also referred to as 3-Pyridazinemethanol, alpha-(2-Chloro-4-fluoro-5-(7-(4-morpholinyl)-4-quinazolinyl)phenyl)-6-methoxy-, (alphaS)-, M 3814.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have pathologically confirmed pancreatic adenocarcinoma. Patients with alternative or mixed histologies (i.e., squamous...
- Received 4-6 months of induction chemotherapy with fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX), fluorouracil, liposomal...
- Patients must have locally advanced pancreatic cancer according to National Comprehensive Cancer Network (NCCN) Guidelines (version 1.2020) on...
- For head or uncinate process tumors:
- Solid tumor contact with superior mesenteric artery \> 180 degrees
You likely can't join if
- 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...
- 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
See the full eligibility criteria
Who can join
- Patients must have pathologically confirmed pancreatic adenocarcinoma. Patients with alternative or mixed histologies (i.e., squamous, neuroendocrine, acinar, colloid) are not eligible
- Received 4-6 months of induction chemotherapy with fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX), fluorouracil, liposomal irinotecan, leucovorin, oxaliplatin (NALIRIFOX), or gemcitabine/Abraxane, as...
- Patients must have locally advanced pancreatic cancer according to National Comprehensive Cancer Network (NCCN) Guidelines (version 1.2020) on pancreas protocol CT scan performed within 21 days of registration. Locally...
- For head or uncinate process tumors:
- Solid tumor contact with superior mesenteric artery \> 180 degrees
- Solid tumor contact with the celiac axis \> 180 degrees
- Solid tumor contact with the common or proper hepatic arteries \> 180 degrees or
- For pancreatic body or tail tumors:
- Solid tumor contact of \> 180 degrees with the superior mesenteric artery or celiac axis
- Solid tumor contact with the celiac axis and aortic involvement or
- Unreconstructible superior mesenteric vein or portal vein due to tumor involvement or occlusion (can be due to tumor or bland thrombus)
- The determination of locally advanced pancreatic cancer and plan for non-operative treatment on this clinical trial must be confirmed through local multi-disciplinary review
- Measurable disease per response evaluation criteria in solid tumors (RECIST) version (v)1.1
- Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of M3814 (peposertib) in combination with hypofractionated radiation in patients \< 18 years of age, children are excluded...
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 60%)
- Leukocytes \>= 4,000/mcL
- Absolute neutrophil count \>= 1.5 x 10\^9/L.
- Hemoglobin \>= 9 g/dL
- Platelets \>= 100 x 10\^9/L
- Total bilirubin =\< 2.0 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =\< 3 x institutional ULN
- Creatinine =\< 1.5 x institutional ULN
- Glomerular filtration rate (GFR) \>= 51 mL/min/1.73 m\^2
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as...
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function. To be eligible for this trial, patients...
- Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and/or family member...
What rules you out
- 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...
- 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...
- 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...
- Patients who cannot discontinue concomitant proton-pump inhibitors (PPIs). Patients may confer with the study doctor to determine if such medications can be discontinued. These must be discontinued \>= 5 days prior to...
- Patients who have received a live attenuated vaccine within 30 days of dosing with M3814 (peposertib)
- Patients with uncontrolled intercurrent illness
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because M3814 (peposertib) is a DNA-protein kinase (PK) inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk...
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of this investigational regimen
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Fairway, Kansas, United States
- Hays, Kansas, United States
- Kansas City, Kansas, United States
- Lawrence, Kansas, United States
- Olathe, Kansas, United States
- Overland Park, Kansas, United States
- Pittsburg, Kansas, United States
- Salina, Kansas, United States
- Topeka, Kansas, United States
- Westwood, Kansas, United States
- Lexington, Kentucky, United States
- Detroit, Michigan, United States
- Farmington Hills, Michigan, United States
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Orange, California, United States; Sacramento, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.