7-ETHYL-10-HYDROXYCAMPTOTHECIN (SN-38) for Pancreatic carcinoma

Inclusion criteria

• {"criterion_text":"- Age ≥18 years.\n- Normal renal function as defined by biochemical parameters as follows: creatinine ≤2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73 m2.\n- Haematological and cardiac function as defined by biochemical and haematological parameters as follows: haemoglobin (Hb) ≥10 g/dL (with preoperative transfusion), platelets ≥80.000/mm3 with intraoperative transfusion, white blood cells (WBC) ≥3.000/mm3, neutrophil count ≥1.500/mm3.\n- Liver function as defined by biochemical parameters as follows: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 4 times the upper limit of normality [ULN]. Recommended serum bilirubin for eligibility is bilirubin ≤ 10 mg/dl (or equivalent value in μmol/L units). Preoperative biliary drainage to be done according to regular practice in each center. Patients in whom preoperative biliary drainage cannot be performed or biliary drainage was not completely effective, individualized decision to be made when bilirubin is ≥ 10 mg/dl (or equivalent value in μmol/L units).\n- Participants must have fully recovered from the acute toxic effects (Grade 3 or above) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this trial.\n- The participant or a legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained prior to any protocol screening procedures.\n- Neoadjuvant chemotherapy is allowed in borderline and/or locally advanced cases borderline completed at least 4 weeks before surgery.\n- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n- Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.\n- Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.\n- Participants diagnosed with: a. Lesion/s of histologically or cytologically confirmed de novo carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas with only locally advanced disease, resectable or borderline resectable. b. Histopathological confirmation of the diagnosis can be done during surgery by means of intraoperative biopsy as per clinical practice. No need of preoperative biopsy.\n- Participants previously treated with chemotherapy will be eligible if they have not had documented progressive disease during treatment.\n- Participants must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion obtained by a validate imaging technique (i.e., magnetic resonance imaging (MRI), computed tomography (CT) scan, PET scan, ultrasounds or others) that can be accurately measured.\n- Participants should have surgically removable lesion/s or what they will be submitted to a pancreatoduodenectomy."}

Exclusion criteria

• {"criterion_text":"- Other malignancies within past 2 years.\n- Contraindication to computed tomography scan (CT).\n- Major surgery within 14 days prior to starting study drug or still in recovery after experiencing surgical complications; neither tumour biopsy nor central line insertion are considered a major surgery.\n- Participants with disease of any major organ system that would compromise their ability to withstand therapy.\n- Pregnancy or lactation. Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.\n- Other relevant concomitant illnesses.\n- Participants’ status post-allogeneic stem cell transplant are not eligible.\n- R2 resections (macroscopic disease remains after surgery).\n- Patients with homozygous UGT1A1 known to be at risk of increased toxicity with irinotecan and SN-38.\n- Active bacterial, viral or fungal infection.\n- Known history of active human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C or chronic liver disease. Testing is not required in the absence of clinical findings or suspicion.\n- Impossibility of ensuring adequate follow-up.\n- Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study."}

Primary endpoints

• {"endpoint_text":"- Serious and non-serious Adverse Events (AE) according to the most updated version of the Common Terminology Criteria for Adverse Events (CTCAE).","definition_or_measurement_approach":"Adverse events are captured and classified according to the most updated version of CTCAE."}
• {"endpoint_text":"- International Patient Safety Goals (IPSG) after pancreatic surgery.","definition_or_measurement_approach":"IPSG after pancreatic surgery (no further definition provided in the record)."}

Secondary endpoints

• {"endpoint_text":"- Local recurrence-free survival (LRFS).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Progression-free survival (PFS).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival (OS).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Pharmacokinetic analysis of multiple plasma samples obtained before and after the implant of CEB-01 to calculate: Area under the concentration-time curve (AUC0-inf), Maximum concentration (Cmax), Time of maximum plasma concentration (Tmax) and Terminal half-life (t1/2) of the active substance SN-38.","definition_or_measurement_approach":"PK parameters to be calculated from multiple plasma samples: AUC0-inf, Cmax, Tmax and t1/2 for SN-38."}

Spain

Earliest CTIS Part Ii Submission Date

20-03-2024

Latest Decision Or Authorization Date

15-04-2025

Processing Time Days

391

Number Of Sites

4

Number Of Participants

39

Primary sponsor

Full Name

Cebiotex S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Contract research organisations

Name

Mfar Clinical Research S.L.

Responsibilities

codes: 1,10,11,5,6,8

Third parties

• {"country":"Spain","full_name":"Kymos S.L.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Hospital Universitario Virgen del Rocío","duties_or_roles":"code: 4","organisation_type":"Health care"}
• {"country":"Spain","full_name":"Mfar Clinical Research S.L.","duties_or_roles":"codes: 1,10,11,5,6,8","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Spain","full_name":"Centro Pfizer – Universidad de Granada – Junta de Andalucía de Genómica e Investigación Oncológica","duties_or_roles":"code: 4","organisation_type":"Educational Institution"}