Study on Quemliclustat and Chemotherapy for Patients with Metastatic Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as pancreatic cancer, specifically a form called metastatic pancreatic ductal adenocarcinoma. This is a condition where cancer has spread from the pancreas to other parts of the body. The study will test a new treatment involving a medication called Quemliclustat (also known by its code name AB680) in combination with chemotherapy drugs nab-paclitaxel and gemcitabine. These treatments will be compared to a placebo combined with the same chemotherapy drugs.

The purpose of the study is to compare the overall survival of patients receiving the new treatment combination against those receiving the placebo combination. Participants in the study will receive their treatments through an intravenous route, which means the medication is given directly into a vein. The study will be conducted over a period of up to 24 months, during which patients will be monitored for their response to the treatment and any side effects they may experience.

Overall survival, which is the time from the start of the study until death from any cause, is the main focus of the study. Other aspects being looked at include how long patients live without the disease getting worse, the rate at which patients respond to the treatment, and the duration of any positive response. The study will also track the safety of the treatments by recording any adverse events or serious side effects. This trial aims to provide valuable information on the effectiveness and safety of Quemliclustat in combination with chemotherapy for treating metastatic pancreatic cancer.

1 joining the trial

Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the experimental treatment, and the other will receive a placebo. This process is called randomization and ensures that the trial results are unbiased.

2 treatment administration

You will receive your assigned treatment through an intravenous (IV) line. This means the medication will be given directly into your bloodstream through a vein.

If you are in the experimental group, you will receive a combination of quemliclustat, paclitaxel albumin-bound, and gemcitabine. If you are in the placebo group, you will receive a placebo along with paclitaxel albumin-bound and gemcitabine.

The exact dosage and frequency of administration will be determined by the study protocol and your healthcare team.

3 monitoring and follow-up

Throughout the trial, you will have regular appointments to monitor your health and the effects of the treatment. This may include physical exams, blood tests, and imaging tests like CT or MRI scans.

Your healthcare team will assess your response to the treatment and check for any side effects. It is important to report any new symptoms or concerns during these visits.

4 end of treatment

The treatment phase of the trial will continue until the study’s end date or until your healthcare team decides it is in your best interest to stop.

After completing the treatment phase, you may have additional follow-up visits to monitor your long-term health and gather more information about the treatment’s effects.

Who Can Join the Study?

Have a confirmed diagnosis of Pancreatic ductal adenocarcinoma (PDAC) that has spread to other parts of the body (metastatic).
Be at least 18 years old or older, depending on the age of consent in your region, at the time of signing the consent form.
Have not received treatment for PDAC in its metastatic stage.
- Previous treatments before surgery (neoadjuvant) or after surgery (adjuvant) are allowed if they were completed at least 12 months before joining the study.
- Previous radiation therapy to relieve symptoms (palliative radiotherapy) is allowed if completed at least 2 weeks before joining the study and any side effects have improved to a mild level (Grade 1 or less).
- Having a bile duct stent or tube is allowed if any related side effects have improved to a mild level (Grade 1 or less) and there are no signs of bile duct blockage.
Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale within 7 days before joining the study. This scale measures how well you can carry out daily activities.
Have at least one tumor that can be measured by a CT scan or MRI and is not in an area that has received radiation therapy before.

Who Cannot Join the Study?

Patients with any other type of cancer besides pancreatic cancer cannot participate.
Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
Patients who have had a heart attack or severe heart disease in the past 6 months cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with severe liver disease cannot participate.
Patients with severe kidney disease cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have an active infection that requires treatment with antibiotics cannot participate.
Patients who have a known allergy to the study drugs cannot participate.
Patients who are participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Centr Georges Francois Leclerc	Dijon	France
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Medical University Of Vienna	Vienna	Austria
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Istituto Oncologico Veneto	Padua	Italy
Institut Jules Bordet	Anderlecht	Belgium
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Krankenhaus Der Barmherzigen Brueder Wien	Vienna	Austria
Katholisches Marienkrankenhaus gGmbH	Hamburg	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Fakultni Nemocnice Brno	Brno	Czechia
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Universita’ Politecnica Delle Marche	Ancona	Italy
ELBLANDKLINIKEN Stiftung & Co. KG	Riesa	Germany
Nemocnice AGEL Novy Jicin a.s.	Novy Jicin	Czechia
Hospital Alvaro Cunqueiro	Vigo	Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany
Clygxx Ljta Bgqvbf	Lyon	France
Iftbua Ipcrdxns Fjhzyjefwxynd Ozwrokewrna	Rome	Italy
Iclkbo	Bonheiden	Belgium
Sxigsvjt Pbgdvqtao Sqb z ooto	Gdynia	Poland
Fgamjwri neoyesdqf Mqteg a Hsavaaf	Prague	Czechia
Alhvtwyup Uxs	Amsterdam	The Netherlands
Ngxeznhd Imgfeeym Oouuogxkp Izi Mxbay Sbvhqwmeuppyzdqpnvexxeuyuora Iztrmnbg Bfiercxi	Cracow	Poland
Uqcdqwfotsnanapordhre Wbciwbuzy Ato	Wuerzburg	Germany
Aafsygg Ueptw Solriraci Lofrch Dc Buexnlc	Bologna	Italy
Ianbvyee Cfmhtv Dxfiviavgtcdrwkkl	L'hospitalet De Llobregat	Spain
Fnrdkcdpt Pqpx Ls Ixtdgyzgveidp Bhhofjoyd Djd Htzlabve Uzmugfgtcvtpj Ls Pbx	Madrid	Spain
Hmxhurum Vsfk dkaudhzb	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	31.01.2025
Belgium	Not recruiting	31.01.2025
Czechia	Not recruiting	31.01.2025
France	Not recruiting	31.01.2025
Germany	Not recruiting	31.01.2025
Italy	Not recruiting	31.01.2025
Poland	Not recruiting	31.01.2025
Spain	Not recruiting	31.01.2025
The Netherlands	Not recruiting	31.01.2025

Trial locations

Investigated drugs:

Quemliclustat is an experimental medication being tested in this clinical trial. It is being studied to see if it can help improve the survival of patients with a specific type of pancreatic cancer when used in combination with other cancer treatments. The goal is to determine if adding quemliclustat to the treatment plan can make the overall treatment more effective.

Nab-paclitaxel is a type of chemotherapy drug used to treat various cancers, including pancreatic cancer. It works by stopping cancer cells from dividing and growing, which can help slow down or stop the progression of the disease. In this trial, nab-paclitaxel is used in combination with other treatments to see if it can improve patient outcomes.

Gemcitabine is another chemotherapy medication that is commonly used to treat pancreatic cancer. It works by interfering with the DNA of cancer cells, preventing them from multiplying. This trial is testing whether combining gemcitabine with other treatments can enhance its effectiveness in treating pancreatic cancer.

Pancreatic cancer – Pancreatic cancer is a disease where malignant cells form in the tissues of the pancreas, an organ located behind the stomach. It often begins in the ducts that carry pancreatic juices, known as exocrine pancreatic cancer. As the disease progresses, it can invade nearby organs and spread to distant parts of the body. Symptoms may not appear until the cancer is advanced, and they can include jaundice, weight loss, and abdominal pain. The disease can affect the body’s ability to digest food and regulate blood sugar. Over time, it can lead to complications such as diabetes and digestive issues.

Metastatic Pancreatic ductal adenocarcinoma (mPDAC) – Metastatic pancreatic ductal adenocarcinoma is a type of pancreatic cancer that has spread beyond the pancreas to other parts of the body. It originates in the ductal cells of the pancreas, which are responsible for transporting digestive enzymes. As the disease advances, it can invade nearby tissues and organs, leading to a range of symptoms such as pain, weight loss, and jaundice. The spread of cancer cells to distant organs, such as the liver or lungs, can cause additional symptoms and complications. This type of cancer can significantly impact the body’s digestive and metabolic functions. The progression of the disease can lead to further health challenges as it affects multiple systems in the body.

Pancreatic ductal adenocarcinoma (PDAC) – Pancreatic ductal adenocarcinoma is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It is characterized by the uncontrolled growth of cells in the pancreatic ducts, which can form tumors. As the disease progresses, it can invade nearby tissues and organs, causing symptoms like abdominal pain, jaundice, and weight loss. The cancer can obstruct the bile duct, leading to digestive issues and changes in liver function. Over time, it may spread to other parts of the body, complicating the disease further. The progression of PDAC can affect the pancreas’s ability to produce enzymes and hormones, impacting digestion and blood sugar regulation.

Trial ID:

2024-513317-12-00

Protocol code:

PRISM-1

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Quemliclustat and Chemotherapy for Patients with Metastatic Pancreatic Cancer

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