Nimotuzumab-pancreatic cancer-adults-Phase IV.

• Register: RPCEC
• Last refreshed on: 1 April 2024
• Main ID: RPCEC00000245
• Date of registration: 30/04/2017
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology
• Public title: Nimotuzumab-pancreatic cancer-adults-Phase IV.
• Scientific title: Evaluation of the safety and effectiveness of CIMAher® (Nimotuzumab) in the treatment of patients with locally advanced adenocarcinoma of pancreas and unresectable or metastatic. Phase IV
• Date of first enrolment: 15/05/2017
• Target sample size: Patient to be recruited during two years. Ideal value: at least 136
• Recruitment status: Recruiting
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000245-En
• Study type: Interventional
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
• Phase: 4

Countries of recruitment

Cuba

Contacts

• Name: Yamilka Sanchez Azcuy
• Affiliation: Center for Cancer Patient Care "III Congreso"

• Name: Yaimarelis Saumell Nápoles
• Affiliation: Center of Molecular Immunology

Key inclusion & exclusion criteria

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


Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Pancreatic Diseases

Digestive System Neoplasms

Digestive System Diseases

Endocrine Gland Neoplasms

Pancreatic Neoplasms

Pancreatic cancer locally advanced unresectable or metastatic

Endocrine System Diseases

Intervention(s)

Group I (experimental): 2 year treatment with Nimotuzumab 400 mg once a week (intravenous) until discontinuation criteria, in combination with Chemotherapy: Gemcitabine 1000mg / m2 (30 min intravenous infusion) days 1, 8, 15, rest for a week and repeat until disease progression; or Capecitabine 1000mg / m2 twice daily (oral), days 1-14, every 3 weeks; or combination 5-Fluouracil (5-Fu) 425mg / m2 (intravenous) (bolus) days 1-5 + folinic acid 20mg / m2 (intravenous) (bolus) days 1-5, every 4 weeks.

Administration, Oral

Nimotuzumab
Gemcitabine

Antibodies, Monoclonal

Antineoplastic Agents

Leucovorin

Antibodies, Monoclonal, Humanized

Administration, Intravenous

Capecitabine

Drug Therapy, Combination

Fluorouracil

Infusions, Intravenous

Primary Outcome(s)

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.

Secondary Outcome(s)

Regarding to Safety
1. Adverse events (AEs). Measurement time: every 3 months until 24 months. The AEs will be measured by:
Type of EA (Name of EA)
a) Seriousness of EA (Serious, not serious)
b) EA intensity (mild, moderate, severe, threatening or disabling the patient's life and death)
c) Causal relationship (very likely, likely, possible, unlikely, unrelated or non-evaluable)
d) Attitude followed by the appearance of EA (temporary or permanent interruption, dose modification, unchanged)
e) Treatment of AE (name of treatment indicated)
f) Outcome of AE (reversible effect, irreversible effect, death or loss of patient follow-up)
g) Batch of nimotuzumab (a batch number of nimotuzumab)
2. Clinical laboratory tests (values of every test parameter classified as “normal, not clinically significant and clinically significant”). Measuring time: before the CT cycle and, them every 3 months until 24 months.
Regarding to effectiveness
1. Global survival (Time from recruitment until death from any cause. If not possible to assess the death of the patient, it will record the last patient news in the clinical health record). Measurement time: 6, 12, 18 y 24 months.
2. Progression-free survival (Time from treatment begin until objective tumor progression or death). Measurement time: 6, 12, 18 y 24 months.
3. Antitumor response (It will be evaluated like “Complete response, partial response, stable disease, disease progression” according to RECIST version 1.1 criteria). Measurement time: every 3 months after treatment begins until 24 months

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Center of Molecular Immunology (CIM)Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable

Results

• Date Posted: 31/10/2021
• Date Completed: 31/10/2021