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Study on the Safety and Tolerability of CEB-01 in Patients with Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for pancreatic cancer. The treatment being tested is called CEB-01, which is a special type of medication delivered through an implantation matrix. The main ingredient in CEB-01 is a chemical substance known as 7-ethyl-10-hydroxycamptothecin. This study aims to understand how safe and tolerable this treatment is for patients with pancreatic cancer.

Participants in the study will receive the CEB-01 treatment, and some may receive a placebo. The study will monitor the safety and any side effects experienced by participants. It will also look at how the body processes the treatment, which is known as pharmacokinetics. This involves taking blood samples to measure how much of the active substance, called SN-38, is in the bloodstream over time. The study will also track how long participants live without the cancer coming back or getting worse.

The trial will follow participants over a period of time to gather information on their health and the effectiveness of the treatment. This includes looking at how long participants live without the cancer returning, known as local recurrence-free survival, and how long they live without the disease progressing, known as progression-free survival. The overall survival of participants will also be measured. The study is expected to continue until 2028, with recruitment starting in 2024.

1 joining the study

Upon joining the study, the participant must meet specific eligibility criteria, including age, renal function, and recovery from previous treatments.

Consent must be provided in writing before any screening procedures begin.

2 screening and preparation

Screening involves various tests to confirm eligibility, such as blood tests and imaging to assess the disease.

Female participants of childbearing potential must undergo a pregnancy test.

3 implantation of CEB-01

The CEB-01 PLGA membrane, containing the active substance 7-ethyl-10-hydroxycamptothecin, is implanted.

This step is crucial for assessing the safety and tolerability of the treatment.

4 monitoring and follow-up

Participants are monitored for any adverse events, both serious and non-serious, following the implantation.

Regular follow-up visits are scheduled to assess the participant’s health and the treatment’s effectiveness.

5 pharmacokinetic analysis

Blood samples are collected before and after the implant to analyze the pharmacokinetics of the active substance.

This analysis helps in understanding how the substance is processed in the body.

6 end of study

The study is estimated to conclude by September 2028.

Final assessments are conducted to evaluate the overall outcomes, including survival rates and recurrence of the disease.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must have normal kidney function, which means certain blood tests show creatinine levels of 2 mg/dl or less, or creatinine clearance of 60 ml/min/1.73 m² or more.
  • Must have normal blood and heart function, shown by blood tests with hemoglobin (Hb) of 10 g/dL or more, platelets of 80,000/mm³ or more, white blood cells (WBC) of 3,000/mm³ or more, and neutrophil count of 1,500/mm³ or more.
  • Must have normal liver function, shown by blood tests with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 4 times the normal limit. Bilirubin levels should be 10 mg/dl or less. If preoperative biliary drainage is not possible or not fully effective, a decision will be made if bilirubin is 10 mg/dl or more.
  • Must have fully recovered from severe side effects (Grade 3 or above) of any previous chemotherapy, immunotherapy, or radiotherapy before joining the trial.
  • Must provide written consent to participate in the study, or a legally authorized guardian must do so.
  • Neoadjuvant chemotherapy, which is treatment given before surgery, is allowed if completed at least 4 weeks before surgery in certain cases.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
  • Female participants who can have children must have a negative pregnancy test at the time of screening.
  • Men and women who can have children must agree to use effective birth control during the study and for 6 months after surgery.
  • Must have a confirmed diagnosis of pancreatic cancer that is locally advanced, resectable, or borderline resectable. This can be confirmed during surgery with a biopsy.
  • Participants who have had chemotherapy before can join if their disease did not get worse during treatment.
  • Must have a disease that can be measured using imaging techniques like MRI, CT scan, PET scan, or ultrasounds.
  • Must have a tumor or tumors that can be surgically removed.

Who Cannot Join the Study?

  • Individuals who are not within the specified age range for the study.
  • Individuals who have medical conditions other than pancreatic carcinoma.
  • Individuals who are not able to safely participate in the study due to other health issues.
  • Individuals who are part of a vulnerable population that may not be suitable for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.09.2024

Trial locations

Investigated drugs:

CEB-01 is a new treatment being studied for its safety and how well it is tolerated in people with pancreatic cancer. It is a special type of membrane made from a material called PLGA, which is designed to be placed in the body. The goal is to see if it can help treat pancreatic cancer by delivering medication directly to the affected area. This study is exploring how the body processes this treatment and whether it can be an effective option for patients.

Investigated diseases:

Pancreatic carcinoma – This is a type of cancer that begins in the tissues of the pancreas, an organ located behind the lower part of the stomach. It often starts in the cells that line the ducts of the pancreas, known as adenocarcinoma. The disease may progress silently at first, often without noticeable symptoms, which can lead to a delay in diagnosis. As it advances, it can cause symptoms such as abdominal pain, weight loss, and jaundice. The cancer can spread to nearby organs and tissues, complicating its progression. It is considered a rare disease, which means it affects a small percentage of the population.

Trial ID:
2024-512742-42-00
Protocol code:
CEB-01-RLPC01-CT
Trial Phase:
Therapeutic exploratory (Phase II)

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