Exploratory clinical trial to assess safety, tolerability efficacy and pharmacokinetics of CEB-01 PLGA membrane in participants with pancreatic cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512742-42-00

Acronym

CEB-01-RLPC01-CT

Enrollment

Registered

2024-06-28

Start date

2024-08-09

Completion date

Unknown

Last updated

2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic carcinoma

Brief summary

Serious and non-serious Adverse Events (AE) according to the most updated version of the Common Terminology Criteria for Adverse Events (CTCAE)., International Patient Safety Goals (IPSG) after pancreatic surgery.

Detailed description

Local recurrence-free survival (LRFS)., Progression-free survival (PFS)., Overall survival (OS)., 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.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Serious and non-serious Adverse Events (AE) according to the most updated version of the Common Terminology Criteria for Adverse Events (CTCAE)., International Patient Safety Goals (IPSG) after pancreatic surgery.	—

Secondary

Measure	Time frame
Local recurrence-free survival (LRFS)., Progression-free survival (PFS)., Overall survival (OS)., 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.	—

Countries

Spain

Outcome results