Nimotuzumab inoperable esophageal epithelial tumors, Phase IV

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Nimotuzumab safety and effectiveness in inoperable esophageal tumors of epithelial origin. Phase IV

Secondary indentifying numbers:

IICRD-EC-163

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology Cuban Ministry of Public Health

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Trials notification

Regulatory instance:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Notification date :

07/04/2016

Reference number:

37-001-16-BFA

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Sandra

Last name:

Gonzalez Fernandez

Medical Specialty :

MD, Second degree specialist in Oncology

Affiliation:

Conrado Benitez Hospital

Postal address:

Ave Los Libertadores s/n

City:

Santiago de Cuba

País:

Cuba

Zip Code:

90500

Telephone:

+53-22652266

+53-22669318

Email address:

sandra.gonzalez@infomed.sld.cu

ensaclin@medired.scu.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Villa Clara, Celestino Hernandez Robau Hospital, Acralys Perdomo Garabito, MD, first degree specialist in Oncology.

Pinar del Rio, III Congreso Hospital, Lucien Boris Bencomo, MD, first degree specialist in Oncology

Matanzas, Jose Ramon Lopez Tabranes Hospital, Edagnys Medina Caraveo, MD, first degree specialist in Oncology

Cienfuegos, Gustavo Aldereguia Hospital, Luis Varona Vazquez, MD, first degree specialist in Oncology.

Sancti Spiritus, Camilo Cienfuegos Hospital, Jorge Alvarez Blanco, MD, first degree specialist in Oncology.

Granma, Manzanillo, Celia Sanchez Hospital, Luis Alberto Villegas Ramos, MD, first degree specialist in Oncology

Camaguey, Manuel Ascunce Hospital, Luis Laureano Soler Porro, MD, first degree specialist in Gastroenterology

Las Tunas, Ernesto Guevara Hospital, Lien Fonseca Chon, MD, first degree specialist in Gastroenterology

Guantanamo, Agostinho Neto Hospital, Felix Santel Odio, MD, first degree specialist in Cirujano

Holguin, Vladimir I. Lenin Hospital, Liuba Mojena Martinez, MD, first degree specialist in Oncology

Ciego de Avila, Antonio Luaces Hospital, Yelec Estrada, MD, first degree specialist in Gastroenterology

Research ethics committees:

Conrado Benitez Hospital, 21/1/16

Celestino Hernandez Robau Hospital, 15/12/15

III Congreso Hospital, 6/1/16

Jose Ramon Lopez Tabranes Hospital, 15/1/16

Gustavo Aldereguia Hospital, 21/1/16

Camilo Cienfuegos Hospital, 21/1/16

Celia Sanchez Hospital, 28/1/16

Manuel Ascunce Hospital, 19/2/16

Ernesto Guevara Hospital, 26/2/16

Agostinho Neto Hospital, 29/2/16

Vladimir I. Lenin Hospital, 18/3/16

Antonio Luaces Hospital, 13/5/16

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

30/06/2016

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Inoperable esophageal tumors of epithelial origin, located in cervical esophagus or intra-thoracic (upper thoracic portion or half) of new diagnosis, relapse or progression.

Health condition(s) code:

Esophageal Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Digestive System Diseases

Gastrointestinal Diseases

Neoplasms, Glandular and Epithelial

Health condition keyword:

inoperable tumors of the esophagus

Intervention(s):

Experimental group (Nimotuzumab): 200 mg intravenous infusion in induction and maintenance scheme Induction: 200 mg once per week for 6 weeks. Maintenance: 200mg every 14 days while the patient not show deterioration of functional capacity (ECOG>3) or until non-tolerable toxicity appears. For newly diagnosed patient: Nimotuzumab + first line of Chemotherapy and/or Radiotherapy (according to the standards treatment). If the patient does not tolerate Chemotherapy/Radiotherapy, they will receive Nimotuzumab as monotherapy For Relapse or progression patients: Nimotuzumab + 2nd line Chemotherapy or as monotherapy if the patient does not tolerate Chemotherapy.

Intervention code:

Antibodies, Monoclonal, Humanized

Drug Therapy

Radiotherapy Chemoradiotherapy

Antibodies, Monoclonal

Combined Modality Therapy

Induction Chemotherapy

Administration, Intravenous

Intervention keyword:

Nimotuzumab

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Incidence of serious adverse events (serious) with causality relationship with the product under study (Very likely, probable or possible). Measuring time: 2 years

Key secondary outcomes:

Safety 1. Occurrence of any Adverse Event-AE: (yes/ no). Measuring time: 2 years 2. AE description (Name of the adverse event). Measuring time: 2 years 3. Duration of the AE (Difference between the start date and the completion of the event). Measuring time: 2 years 4. Intensity of AE (Common Toxicity Criteria (CTCAE) version 4.0. 1. Light, 2.Moderate, 3.Severe, 4.Very severe, 5.Death). Measuring time: 2 years 5. Gravity (Seriousness): Critical event / No serious. Measuring time: 2 years 6. Causality relationship (1.Very likely 2.Likely 3.Possible, 4. Unlikely, 5.Unrelated, 6.Unknown). Measuring time: 2 years 7. Attitude towards drug (1. No change 2. Dose reduction 3. Temporary discontinuation of treatment. 4. Definitive Treatment discontinuation). Measuring time: 2 years 8. Outcome of the AE (1. reversible effect. Measuring time: 2 years 2. Effect 3. Death 4. Irreversible loss of patient monitoring). Measuring time: 2 years 9. Treatment (Name and dosage of the treatment received). Measuring time: 2 years 10. Batch (Number of Nimotuzumab bulb): Measuring time: 2 years 11. Physical exam (Vital signs, Height, Weight, ECOG). Measuring time: 2 years 12. Laboratory tests (Hematology: Hemoglobin, Hematocrit, White blood cell count with differential, Platelet count; Biochemistry: Glutamic-oxaloacetic transaminase / aspartate aminotransferase (GOT/AST), and glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), Bilirubin, Alkaline Phosphatase, Glycemia, Total protein, Creatinine, Normal urine (OR))). Measuring time: 2 years Effectiveness 1. Overall survival-OS (Time from the date of inclusion of each patient until the date of death or the last date that has news of the patient. Measuring time: 2 years 2. Progression-free survival-PFS (Time from the date of inclusion of each patient until the date of determination of the progression, death or the last date that the patient has the news). Measuring time: 2 years 3. Quality of life (Questionnaire EORTC QLQ-C30-version 3-, EORTC QLQ-OES18-version 3). Measuring time: 2 years 4. Clinical Response (RECIST version 1.1. Complete response (CR), partial response (PR) stable disease (SD) and progressive disease (PD)). Measuring time: 2 years

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Patients who met the diagnostic criteria. 2. Patient express written participate in the study by signing the informed voluntary consent. 3. Patient aged ≥ 18 years. 4. Life expectancy equal to or greater than 6 months. 5. Clinical status as criteria ECOG ≤ 2

Exclusion criteria:

1. Pregnancy, postpartum and breastfeeding 2. Patients with a second tumor concomitant with the exception of basal or squamous cell skin carcinoma in situ and neck carcinoma treated or diagnosed by CT brain metastasis, progression or uncontrolled. 3. Presence of chronic disease or uncontrolled intercurrent (including active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia and psychiatric or social diseases that may limit adherence to clinical trial requirements), or congenital or acquired immunodeficiency at the time of inclusion. 4. Known hypersensitivity to any component of the Nimotuzumab formulation. 5. Presence of allergic conditions or septic acute or severe processes. 6. The patient has received prior treatment with Nimotuzumab or other biological therapy 6 months prior to enrollment, or is receiving other investigational product.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

4

Target sample size:

Patients recruited within a period of two years

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yaimarelis

Last Name:

Saumell Napoles

Specialty:

Bachelor in Pharmaceutical Sciences

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 y 15. Reparto Atabey. Playa.

City:

Havana

País:

Cuba

Zip Code:

11600, box 16040

Telephone:

+537-214-3144

Email :

yaimarelis@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Yaimarelis

Last Name:

Saumell Napoles

Specialty:

Bachelor in Pharmaceutical Sciences

Affiliation:

Center of Molecular Immunology

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600, box 16040

Telephone:

+537 214-3144

Email :

yaimarelis@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000215

Date of Registration in Primary Registry:

30/06/2016

Record Verification Date:

2016/06/30

Next update date:

2017/06/30

Link to the spanish version:

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Nimotuzumab inoperable esophageal epithelial tumors, Phase IV

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