Study on the Safety and Effectiveness of ABTL0812 with Drug Combination 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 called metastatic pancreatic cancer, which is a serious condition where cancer cells have spread from the pancreas to other parts of the body. The study is testing a new treatment called ABTL0812, which is taken as a capsule. This treatment is being tested in combination with a group of chemotherapy drugs known as FOLFIRINOX. FOLFIRINOX is a combination of four different drugs: fluorouracil, oxaliplatin, irinotecan, and calcium folinate. These drugs are usually given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to find out how safe and effective the combination of ABTL0812 and FOLFIRINOX is for treating metastatic pancreatic cancer. The study is divided into two phases. In the first phase, researchers will focus on the safety of the treatment combination. In the second phase, they will compare the effectiveness of ABTL0812 with FOLFIRINOX against FOLFIRINOX with a placebo. The study will look at how long patients live without the cancer getting worse, which is known as progression-free survival.

Participants in the study will receive either the new treatment combination or the standard treatment with a placebo. The study will monitor the participants’ health and response to the treatment over time. This research aims to provide new insights into potential treatments for metastatic pancreatic cancer, offering hope for improved outcomes for patients with this challenging condition.

1 Phase I: Initial Treatment

The initial phase involves assessing the safety of the combination of ABTL0812 with FOLFIRINOX. This phase is open-label, meaning all participants receive the treatment.

ABTL0812 is administered in capsule form for oral use. The specific dosage and frequency will be determined by the study team.

FOLFIRINOX is a combination of drugs including calcium folinate, fluorouracil, oxaliplatin, and irinotecan hydrochloride. These are given through intravenous infusion.

2 Phase I: Monitoring and Assessment

During this phase, regular monitoring of health status is conducted to determine the recommended dose for Phase II.

Blood samples are collected for pharmacokinetic analysis to understand how the body processes the drugs.

Additional blood tests may include analysis of specific biomarkers such as TRIB3 and CHOP.

3 Phase II: Randomized Treatment

In this phase, participants are randomly assigned to receive either ABTL0812 with FOLFIRINOX or FOLFIRINOX with a placebo.

The goal is to compare the efficacy of the two treatment combinations in terms of progression-free survival.

4 Phase II: Ongoing Monitoring

Participants undergo regular assessments to monitor disease progression and response to treatment.

Blood samples continue to be collected for pharmacokinetic analysis and biomarker studies.

Questionnaires are used to evaluate quality of life during the study.

5 End of Study

The study is estimated to conclude by April 2025.

Final assessments will be conducted to evaluate overall survival and other outcomes.

Who Can Join the Study?

The patient must have a confirmed diagnosis of pancreatic cancer, specifically carcinoma, adenocarcinoma, or ductal adenocarcinoma.
The patient must have certain liver enzyme levels (AST and ALT) that are not more than 2.5 times the normal limit, or not more than 5 times if there is liver involvement.
The patient must have alkaline phosphatase levels not more than 2.5 times the normal limit, or not more than 5 times if there is liver involvement.
The patient must have a kidney function test result, called the glomerular filtration rate (GFR), of at least 60 mL/min/1.73 m².
For Phase II patients, if possible, a sample of the tumor tissue or cells should be provided for analysis.
For patients in Spain and France, all premenopausal women and men with fertile partners must use two forms of effective birth control during the study and for 6 months after the last dose. In France, women should continue birth control for up to 9 months after the last chemotherapy session.
The patient must be willing and able to give informed consent, which means they understand the study and agree to participate.
The patient must be able and willing to attend study visits, receive treatment, undergo testing, and follow the study rules.
The patient must have confirmed metastatic disease, meaning the cancer has spread to other parts of the body.
The patient must have measurable disease according to specific guidelines, with at least one “target lesion” to assess response. Tumors in areas that have been treated with radiation will not be used unless they show progression.
The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1, which indicates they are fully active or have some symptoms but do not need bed rest.
The patient must be older than 18 years old.
For patients in Spain, they must have adequate blood cell counts: a neutrophil count of at least 1.5×10⁹/L, a platelet count of at least 100×10⁹/L without transfusion, and hemoglobin of at least 10 g/dL.
For patients in France, they must have adequate blood cell counts: a neutrophil count of at least 2.0×10⁹/L, a platelet count of at least 100×10⁹/L without transfusion, and hemoglobin of at least 10 g/dL.
The patient must have a total bilirubin level not more than 1.5 times the normal limit.
The patient must have an albumin level of at least 3.3 g/dL.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not fully recovered from previous cancer treatments.
Patients with serious heart problems.
Patients with uncontrolled high blood pressure.
Patients with active infections that need treatment.
Patients who are pregnant or breastfeeding.
Patients who have had another cancer in the past 5 years, except for certain skin cancers or in situ cervical cancer.
Patients who have a known allergy to the study drugs.
Patients who are participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients with severe liver or kidney problems.
Patients with a history of certain lung diseases.
Patients who have had a major surgery within the last 4 weeks.
Patients with a history of certain neurological or psychiatric disorders.
Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital General Universitario Morales Meseguer	Murcia	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Centro Oncologico De Galicia	A Coruna Galicia	Spain
Hfwvnauo Ualqibxduuqua Acmdv db Vggkapge	Lleida	Spain
Ifepcpeyb Cqkbtge dt Obvtnifpd (hwf Ghxifcu &dbqked Hgytvthz Jtasz Tzupfx	Girona	Spain
Hgwjaxtd Ukdzuikdngnwd Hedsysrb Thwbi y Pgbdwq Iptkrqnx Cwqzgk dlzundngnrefoglre (lown	Badalona	Spain
Hummolad Vjec dxkhslln	Barcelona	Spain
Ixrofqqs Pycnhfdudqichbo Cquczy Csqwvb	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	22.04.2021
Spain	Not recruiting	22.04.2021

Trial locations

Investigated drugs:

ABTL0812 is an experimental medication being studied for its potential to treat metastatic pancreatic cancer. In this clinical trial, it is being tested to see if it can be safely combined with other cancer treatments and to evaluate its effectiveness in slowing down the progression of the disease.

FOLFIRINOX is a combination of chemotherapy drugs used to treat pancreatic cancer. It includes several medications that work together to stop the growth of cancer cells. In this trial, FOLFIRINOX is used as a standard treatment to compare the effects of adding ABTL0812.

Metastatic pancreatic ductal adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas and has spread to other parts of the body. It is characterized by the uncontrolled growth of cells in the pancreatic ducts, which can invade nearby tissues and organs. As the disease progresses, it can cause symptoms such as abdominal pain, weight loss, and jaundice. The spread of cancer cells to distant organs, known as metastasis, often complicates the condition. This type of cancer is typically aggressive and can be challenging to manage. The progression of the disease can vary, but it often involves the gradual worsening of symptoms and increased difficulty in controlling the spread of cancer cells.

Trial ID:

2024-515379-36-00

Protocol code:

ABT-C11-2020

NCT ID:

NCT04431258

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of ABTL0812 with Drug Combination for Patients with Metastatic Pancreatic Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?