imotuzumab-pancreatic cancer-adults-Phase IV.

Phase 4

Recruiting

• Conditions: Pancreatic cancer locally advanced unresectable or metastatic; Pancreatic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

• Registration Number: RPCEC00000245
• Lead Sponsor: Center of Molecular Immunology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-30
• Study Completion: 2021-10-31
• Results First Posted: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the diagnostic criteria.
2. Patient who provides written consent to participate in the study.
3. Patient with age equal to or greater than 18 years.
4. Life expectancy equal to or greater than 3 months.
5. Clinical status according to criteria of ECOG equal to or greater than 2
6. Patients receiving treatment with QT.
7. Laboratory parameters within the limits established in the protocol.

Exclusion Criteria

1. Patient pregnant, lactating or puerperal.
2. Patient with a second primary tumor.
3. Patient with chronic or uncontrolled intercurrent diseases (eg heart disease, diabetes, high blood pressure).
4. Patient with a history of hypersensitivity to any component of the formulation of Nimotuzumab or chemotherapy.
5. Patient who received Nimotuzumab or other biological therapy 6 months prior to enrollment or is receiving another research product.
6. Patient childbearing age who do not accept use appropriate contraceptive methods

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events related to Nimotuzumab (Adverse events classified as serious” and with a causality relationship classified as very likely, likely or possible” with the nimotuzumab). Measuring time: every 3 months until 24 months.