Revisiones para CIMAvax-EGF vaccine Predictor Phase IV | Registro Público Cubano de Ensayos Clínicos

--- 21 Enero 2021 - 4:48pm por CIM
+++ 19 Julio 2023 - 2:32pm por Gladys
--10-13 04:00:00
 Havana, Carlos M. Portuondo Primary Care Unit,  Madelaine Serra Urra, MD, Family Doctor
-Havana,  Elpidio Berovides Primary Care Unit, Barbara de la Caridad Alonso Perez, MD, Family Doctor
+Havana,  Elpidio Berovides Primary Care Unit, Barbara de la Caridad Alonso Perez, MD Family Doctor
 Havana, Julio A. Mella Primary care Unit, Dr. Jose Ramon Gomez Perez, MD, Family Doctor
 Havana, Lidia y Clodomira Primary care Unit, Miosity Yero Iser, MD, Family Doctor
 Villa Clara, Jose Ramon Leon Acosta Primary care unit,  Lienay Mollineda Leon, MD, Family Doctor
 Villa Clara, Marta Abreu Primary care Unit, Menelio Norvel Noriega, MD, Family Doctor
-Villa Clara, Roberto Fleites Primary Care unit, Maria Cecilia Garcia Granela, MD, Family Doctor
+Villa Clara, Roberto Fleites Primary Care Unit, Maria Cecilia Garcia Granela, MD, Family Doctor
+Villa Clara, Mario A Pérez Primary Care Unit, Dra. Yoilé Hernández Núñez, MD, Family Doctor
+Villa Clara, Abel Santamaría Primary Care Unit, Dr. Juan Ricardo Sotés Martínez, MD, Family Doctor
+Villa Clara, Octavio de la Concepción y Pedraja Primary Care Unit, Dra Elba Valdés Rodríguez, MD, Family Doctor
+Villa Clara, Pablo Agüero Primary Care Unit, Dra Tania Aguila Carballo, MD, Family Doctor
+Villa Clara, XXX Aniversario Primary Care Unit, Dra. Maylu Rita del Río Hernández, MD, Family Doctor
+Villa Clara, Juan B Zayas Primary Care Unit, Dra. Yaneisi Blanco Paz, MD, Family Doctor
+Villa Clara, Manuel Piti Fajardo Primary Care Unit, Dra. Laudis Solano Caro, MD, Family Doctor
+Villa Clara, Juan B Contreras Primary Care Unit, Dr. Diandy Ruiz Moya, MD, Family Doctor
+Villa Clara, 50 Aniversario Primary Care Unit, Dr. René Luis Morán Rodríguez, MD, Family Doctor
+Mayabeque, Hospital Leopoldito Martínez, Dra. Yuneysi Casanova Pineda, MD, First Degree Especilist in Oncology
+Mayabeque, Rosa E. Simeón Primary Care Unit, Dra. Natacha Escobar Galán, Clinician
+Mayabeque, Pablo Noriega Primary Care Unit , Dra. Marino Lorenzo Sarcines, Clinician
+Mayabeque, Raúl Currás Primary Care Unit, Dra. Susana Mieres González, MD, Family Doctor
+Mayabeque, Noelio Capote Primary Care Unit , Dra. Miria Brito González, Clinician
+Mayabeque, Emilia de Córdova Primary Care Unit, Dra. Adiley Gutiérrez Acosta, MD, Family Doctor
+Mayabeque, Humberto Castelló Primary Care Unit, Dra. Elda Vazquez, MD, Family Doctor
+Mayabeque, Felo Echezarreta Primary Care Unit, Dra. Yenisleidys Peña, MD, Family Doctor
+Mayabeque, Alberto Fernández Primary Care Unit, Dra. Yamany González Solá, MD, Family Doctor
+Mayabeque, Luis Li Trigen Primary Care Unit, Dra. Inés María Crespo Cordero, MD, Family Doctor
+Mayabeque, María Emilia Alfonso Primary Care Unit, Dr. Orlando Vasaco Hong, Clinician
+Artemisa, Hospital Comandante Pinares, Dra. Yisel Blanco Herrera,MD, First Degree Especilist in Oncology
+Artemisa, Hospital Camilo Cienfuegos, Dra. Zahirys González Piloto, MD, First Degree Especilist in Oncology
+Artemisa, Eduardo Díaz Primary Care Unit, Dra. Elena Lucrecia Silvera Carcache, MD, Family Doctor
+Artemisa, Pedro Esperón Primary Care Unit, Dr. Mauricel Ortega Sánchez, MD, Family Doctor
+Artemisa, José Hipólito Pasos Primary Care Unit, Dra. Susel Vilier Lores, MD, Family Doctor
+Artemisa, Tomas Romay Primary Care Unit, Dra. Yaima de la Caridad Vázquez Torres, MD, Family Doctor
+Matanzas, José Ramón López Tabranes Hospital, Dra. Kirenia Camacho, MD, First Degree Especilist in Oncology
+Matanzas, José Luis Dubrocq Primary Care Unit , Dr. Poncio Blanco Mustelier, MD, Family Doctor
+Matanzas, Carlos Juan Finlay Primary Care Unit, Dra. Yurier Acevedo Pérez, MD, Family Doctor
+Matanzas, José Antonio Echevarría Primary Care Unit, Dra. Matilde Ugarte Hernández, MD, Family Doctor
+Matanzas, Siete de Diciembre Primary Care Unit, Dra. Anisley Alvarez Gómez, MD, Family Doctor
+Matanzas, Rene Vallejo Primary Care Unit, Dr. Ihosvanny E.Carreño Rolando, MD, Family Doctor
+Matanzas, José Machado Primary Care Unit, Dra. Yaumara Martínez García, MD, Family Doctor
+Cienfuegos, Hospital Gustavo Aldereguía, Dra. Yoana Herrera Leyva, MD, First Degree Especilist in Oncology
+Cienfuegos, Manuel Fajardo Primary Care Unit, Dr. Rigoberto A. Hermida Acosta, MD, Family Doctor
+Cienfuegos, Manuel Piti Fajardo Primary Care Unit, Dra. Milagros Ayo Pérez, MD, Family Doctor
+Cienfuegos, Octavio de la Concepción y Pedraja Primary Care Unit, Dra. Gloria I. Lara Calderín, MD, Family Doctor
+Cienfuegos, Laboral Area 7, Dra. Maritza Monzón Delgado, MD, Family Doctor
+Sancti Espíritus, Camilo Cienfuegos Hospital, Dra. Niurelkys Fardales Rodríguez, MD, First Degree Especilist in Oncology
+Sancti Espíritus, Sur Primary Care Unit, Dr. Lázaro Menéndez Pérez , MD, Family Doctor
+Sancti Espíritus, Manuel de Jesús Lara Canteno Primary Care Unit, Dr. Julio Ugando, MD, Family Doctor
+Sancti Espíritus, Carlos J Finlay, Dr. Ernel Gómez Cantero, MD, Family Doctor
+Ciego de Ávila, Antonio Luaces Hospital, Dr. Loisel Bello Ulloa, MD, First Degree Especilist in Oncology
+Ciego de Ávila, Roberto Rodríguez Hospital, Dra. Liannys Armas Espinosa, MD, First Degree Especilist in Oncology
+Ciego de Ávila, Docente Norte Primary Care Unit, Dra. Odelaine Guzmán Pérez, MD, Family Doctor
+Ciego de Ávila, Julio Castillo Primary Care Unit, Dra. Yudit de Corte Gutiérrez, MD, Family Doctor
+Ciego de Ávila, Diego del Rosario Primary Care Unit, Dr. Olegario R. Sánchez Real, MD, Family Doctor
+Ciego de Ávila, Juan Olimpo Varcárcel Primary Care Unit, Dra. Evelyn Sánchez Navarro, MD, Family Doctor
+Ciego de Ávila, José Agustín Mas Naranjo Primary Care Unit, Dra. Maryoli Sánchez Smith, MD, Family Doctor
+Ciego de Ávila, Mario Páez Inchausti Primary Care Unit, Dra. Yaiczat Torres Rojas, MD, Family Doctor
+Ciego de Ávila, Raúl Ortiz Primary Care Unit, Dra. Eliuska Ramírez Martínez, MD, Family Doctor
+Ciego de Ávila, Doña Emilia González Primary Care Unit , Dra. Liudmila Yumar Rodríguez, MD, Family Doctor
+Camagüey, María Curie Hospital, Dra. Mónica Limia Pacheco, MD, First Degree Especilist in Oncology
+Camagüey, Julio A Mella, Dra. Mabel Agramonte Cuan, MD, Family Doctor
+Camagüey, Previsora Primary Care Unit, Dra. Arelys Guerra de la Vega, MD, Family Doctor
+Camagüey, José Martí Primary Care Unit, Dra. María de los Ángeles Garrido Pérez, MD, Family Doctor
+Camagüey, Joaquín de Agüero Primary Care Unit, Dr. Jorge Luis Purniel Rodríguez, MD, Family Doctor
+Camagüey, C Agramonte, Dr. Lem Guzmán Matías, MD, Family Doctor
+Guantánamo, Hospital Agostino Neto , Dra. Liuvia Vazquez Balart, MD, First Degree Especilist in Neumology
+Guantánamo, Francisco Castro Primary Care Unit, Dra. Magdalis De La Cruz Camajuani, MD, Family Doctor
+Guantánamo, Asdrúval López Vázquez Primary Care Unit, Dra. María del Carmen Martínez Rodríguez, MD, Family Doctor
+Guantánamo, Ciro Frías Cabrera Primary Care Unit, Dra. Yoalis Matos Gamboa, MD, Family Doctor
+Guantánamo, IV Congreso Primary Care Unit, Dra. Eliset Cobas Navarro, MD, Family Doctor
+Guantánamo, Gilberto Isalgué Primary Care Unit, Dra. Yamilka Blanco Sarracent, MD, Family Doctor
+Las Tunas, Hospital Ernesto Guevara, Dra. Elizabeth Pérez Velázquez, MD, First Degree Especilist in Oncology
+Las Tunas, Romárico Oro Primary Care Unit, Dra. Belkis Teresa Villegas, MD, Family Doctor
+Las Tunas, Guillermo Tejas Primary Care Unit, Dr. Ariel Labrada Salas, Clinician
+Las Tunas, 7 de Noviembre Primary Care Unit, Dra. Idania Grau Martínez, MD, Family Doctor
+Las Tunas, Gustavo Aldereguía Primary Care Unit, María Onella Silva Silva, MD, Family Doctor
+Granma, Celia Sánchez Hospital, Dr. Conrado Luis Mustelier Rosales, MD, First Degree Especilist in Oncology
+Granma, Carlos Manuel de Céspedes Hospital, Dr. Carlos Gonzáles, MD, First Degree Especilist in Oncology
+Granma, Maximo Gómez Primary Care Unit, Dra. YenisNelsis Sánchez Cadrelo, MD, Family Doctor
+Granma, Edor de los Reyes Primary Care Unit, Dra. Elisabeth Menéndez. Montoya, MD, Family Doctor
+Granma, Jimmy Hirzell Primary Care Unit, Dra. Niurka Bencosme Rodríguez, MD, Family Doctor
+Granma, Juan Enrique de la Paz Primary Care Unit, Dra. Lesyanis Tamaño Muñoz, MD, Family Doctor
+Granma, Angel Ortiz Primary Care Unit, Dra. Zenaida Carbonell, MD, Family Doctor
+Granma, Raúl Podia Saborit Primary Care Unit, Dra. Odalys Álvarez Suarez, MD, Family Doctor
+Granma, Manuel Sánchez Silveira Primary Care Unit, Dr. Fernando Sánchez Torres, MD, Family Doctor
+Granma, René Vallejo Primary Care Unit, Dr. Ernesto Yero Fonseca, MD, Family Doctor
+Granma, Faustino Pérez Primary Care Unit, Dr. Ernesto Rafael Tamayo Pérez, MD, Family Doctor
+Granma, Ernesto Guevara Primary Care Unit, Dr. Yobanis Ortiz Ceruto, MD, Family Doctor
+Granma, Guillermo García Polanco Primary Care Unit, Dra. Liset Carrazana Rodríguez, MD, Family Doctor
+Granma, Joel Benítez Primary Care Unit, José Jacinto Mosqueda Silva, MD, Family Doctor
+Pinar del Río, III Congreso Hospital, Dra. Bárbara Iglesias Castillo, MD, Family Doctor
+Pinar del Río, Ernesto Guevara Primary Care Unit, Dr. Dagoberto Quintana Mejías, MD, Family Doctor
+Pinar del Río, Juan B Zayas Primary Care Unit, Dr. Deyli Miranda Prieto, MD, Family Doctor
+Pinar del Río, José Elias Borges Primary Care Unit, Dra. Greidys Miranda Álvarez, MD, Family Doctor
+Pinar del Río, Fermín Valdez Domínguez Primary Care Unit, Dra. María Cristina Valle Plasencia, MD, Family Doctor
+Pinar del Río, Pedro Borras Primary Care Unit, Dr. Gustavo Hernández Díaz, MD, Family Doctor
+Pinar del Río, Elena Fernández Castro Primary Care Unit, Dra. Ivet M. Rabelo Hernández, MD, Family Doctor
+Pinar del Río, 5 de septiembre Primary Care Unit, Dra. Dianelis Martínez Rojas, MD, Family Doctor
+Pinar del Río, Turcios Lima Primary Care Unit, Dr. Miguel Azcuy Ruiz, MD, Family Doctor
+Pinar del Río, Hermanos Cruz Primary Care Unit, Dr. Guillermo L. Herrera Miranda, MD, Family Doctor
+Pinar del Río, Epifanio Rojas Gil Primary Care Unit, Dra. Cruzmaida Reyes Sablón, MD, Family Doctor
+Pinar del Río, Modesto Gómez Primary Care Unit, Dra. Mileidys Naranjo Rdguez, MD, Family Doctor
+Pinar del Río, Manuel Piti Fajardo Primary Care Unit, Dr. Ricardo Braña Valdés, MD, Family Doctor
+Santiago de Cuba, Juan Bruno Zayas Hospital, Dra. Justa Carmen Columbie Reguiferos, MD, First Degree Especilist in Oncology
+Santiago de Cuba, Hospital Saturnino Lora, Dr. Leonardo Lobaina Lambert, MD, First Degree Especilist in Oncology
+Santiago de Cuba, Camilo Torres Primary Care Unit, Dra. Isabel María Rosabal Rosas, MD, Family Doctor
+Santiago de Cuba, Giraldo Aponte Primary Care Unit, Dra. Nadine Ariadna Ramos Silveira, MD, Family Doctor
+Santiago de Cuba, Eduardo Mesa Primary Care Unit, Dra. Annia Chaveco Barcena, MD, Family Doctor
+Santiago de Cuba, José Martí Primary Care Unit, Dra. Vivian Matos Trujillo, MD, Family Doctor
+Santiago de Cuba, Carlos J Finlay Primary Care Unit, Dr. Eliécer Pérez Fuentes, MD, Family Doctor
+Santiago de Cuba, Cruce de Los Baños Primary Care Unit, Dra. Yasmín Escalante Aliaga, MD, Family Doctor
+Santiago de Cuba, Victoria de Girón Primary Care Unit, Dra. Mariluz Vazquez, MD, Family Doctor
+Santiago de Cuba, América 1 Primary Care Unit, Dra. Dianelis Oliva Ramírez, MD, Family Doctor
+Santiago de Cuba, Alberto Fernández Primary Care Unit, Dr. Leonardo Lobaina Lambert, MD, Family Doctor
+Santiago de Cuba, Nestor López Cuba Primary Care Unit, Dr. Ricardo Díaz Galán, MD, Family Doctor
+Santiago de Cuba, 30 de Noviembre Primary Care Unit, Dra. Elizabeth Dosil Bernal, MD, Family Doctor
+Holguín, Vladimir Ilich Lenin Hospital, Dra. Migdalia Corella San Nicolás, MD, First Degree Especilist in Oncology
+Holguín, Mario Gutiérrez Ardaya Primary Care Unit, Dr. Raúl Bermúdez Pino, MD, Family Doctor
+Holguín, Máximo Gómez Báez Primary Care Unit, Dra. Maira Rojas Pérez, MD, Family Doctor
+Holguín, José Ávila Serrano Primary Care Unit, Dr. Jorge Vega Abascal, MD, Family Doctor
+Holguín, Mario muñoz Monroe Primary Care Unit, Dra. Kersting María Leyva Rojas, MD, Family Doctor
+Holguín, Rolando Ricardo Estrada Primary Care Unit, Dra. Greisy Severina Súarez Gómez, MD, Family Doctor
-Pending
+Complete
+Not entered
--12-14 05:00:00
+-12-14 00:00:00
-Ramon
+Ramón
-First degree specialist in Oncology
+MD, First degree specialist in Oncology
+-11-30T00:00:00
+-04-30T00:00:00
-Maria
+Pedro
-Acelia
+Pablo
-Marrero Miragaya
+Guerra Chaviano
-Fist Degree Specialist in General Surgery
+Industrial engineering, MSc. in Clinical Trials
-BSc. in Farmaceutical Sciences
+BSc. in Farmaceutical Sciences, MSc. in Toxicology
-/12/14
+/08/27
-/12/14
+/08/27
-Center of Molecular Immunology (CIM)
+Center of Molecular Immunology (CIM) Cuban Ministry of Public Health (MINSAP)
-Cuban Ministry of Public Health (MINSAP)

Revisión de 19 Julio 2023 - 2:32pm

CIMAvax-EGF vaccine Predictor Phase IV

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:

Security of CIMAvax-EGF® vaccine for the treatment of patients with NSCLC in advanced stages. Effectiveness exploration according to baseline concentrations of EGF. phase IV

Secondary indentifying numbers:

IICRD-EC-157

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

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

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)

Reference number:

37.003.15BF4

Principal investigator

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

First name:

Ramón

Midle name:

Alberto

Last name:

Ortiz Carrodeguas

Medical Specialty :

MD, First degree specialist in Oncology

Affiliation:

Celestino Hernandez Robau Hospital

Postal address:

Cuba Street 569, between Hospital and Alejandro Oms, Santa Clara

City:

Villa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-042279442

+53-042271202

Email address:

ramonoc@hchr.vcl.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:

Havana, Carlos M. Portuondo Primary Care Unit, Madelaine Serra Urra, MD, Family Doctor

Havana, Elpidio Berovides Primary Care Unit, Barbara de la Caridad Alonso Perez, MD Family Doctor

Havana, Julio A. Mella Primary care Unit, Dr. Jose Ramon Gomez Perez, MD, Family Doctor

Havana, Lidia y Clodomira Primary care Unit, Miosity Yero Iser, MD, Family Doctor

Havana, Raul Gomez Garcia Primary Care Init, Abel Perez Gonzalez, MD, Family Doctor

Havana, Miguel Enriquez hospital , Juan Carlos Brosales, MD, First Degree Especilist in Oncology

Havana, Luis Galván Primary Care Unit, Zumara Grifi, MD, Family Doctor

Havana, Federico Capdevila Primary Care Unit, Ileana Aransola, MD, First degree specialist in internal Medicine

Havana, Efrain Mayor Primary care Unit, Julio A. Muro, MD, First degree specialist in internal Medicine

Villa Clara, Chiqui Gomez Primary Care unit, Margot Gonzalez Llerena, MD, Family Doctor

Villa Clara, Santa Clara Primary Care unit, Maribel Alonso Ledo, MD, Family Doctor

Villa Clara, XX Aniversario Primary care Unit, Maritza Artiles Morales, MD,Family Doctor

Villa Clara, Jose Ramon Leon Acosta Primary care unit, Lienay Mollineda Leon, MD, Family Doctor

Villa Clara, Marta Abreu Primary care Unit, Menelio Norvel Noriega, MD, Family Doctor

Villa Clara, Roberto Fleites Primary Care Unit, Maria Cecilia Garcia Granela, MD, Family Doctor

Villa Clara, Mario A Pérez Primary Care Unit, Dra. Yoilé Hernández Núñez, MD, Family Doctor

Villa Clara, Abel Santamaría Primary Care Unit, Dr. Juan Ricardo Sotés Martínez, MD, Family Doctor

Villa Clara, Octavio de la Concepción y Pedraja Primary Care Unit, Dra Elba Valdés Rodríguez, MD, Family Doctor

Villa Clara, Pablo Agüero Primary Care Unit, Dra Tania Aguila Carballo, MD, Family Doctor

Villa Clara, XXX Aniversario Primary Care Unit, Dra. Maylu Rita del Río Hernández, MD, Family Doctor

Villa Clara, Juan B Zayas Primary Care Unit, Dra. Yaneisi Blanco Paz, MD, Family Doctor

Villa Clara, Manuel Piti Fajardo Primary Care Unit, Dra. Laudis Solano Caro, MD, Family Doctor

Villa Clara, Juan B Contreras Primary Care Unit, Dr. Diandy Ruiz Moya, MD, Family Doctor

Villa Clara, 50 Aniversario Primary Care Unit, Dr. René Luis Morán Rodríguez, MD, Family Doctor

Mayabeque, Hospital Leopoldito Martínez, Dra. Yuneysi Casanova Pineda, MD, First Degree Especilist in Oncology

Mayabeque, Rosa E. Simeón Primary Care Unit, Dra. Natacha Escobar Galán, Clinician

Mayabeque, Pablo Noriega Primary Care Unit , Dra. Marino Lorenzo Sarcines, Clinician

Mayabeque, Raúl Currás Primary Care Unit, Dra. Susana Mieres González, MD, Family Doctor

Mayabeque, Noelio Capote Primary Care Unit , Dra. Miria Brito González, Clinician

Mayabeque, Emilia de Córdova Primary Care Unit, Dra. Adiley Gutiérrez Acosta, MD, Family Doctor

Mayabeque, Humberto Castelló Primary Care Unit, Dra. Elda Vazquez, MD, Family Doctor

Mayabeque, Felo Echezarreta Primary Care Unit, Dra. Yenisleidys Peña, MD, Family Doctor

Mayabeque, Alberto Fernández Primary Care Unit, Dra. Yamany González Solá, MD, Family Doctor

Mayabeque, Luis Li Trigen Primary Care Unit, Dra. Inés María Crespo Cordero, MD, Family Doctor

Mayabeque, María Emilia Alfonso Primary Care Unit, Dr. Orlando Vasaco Hong, Clinician

Artemisa, Hospital Comandante Pinares, Dra. Yisel Blanco Herrera,MD, First Degree Especilist in Oncology

Artemisa, Hospital Camilo Cienfuegos, Dra. Zahirys González Piloto, MD, First Degree Especilist in Oncology

Artemisa, Eduardo Díaz Primary Care Unit, Dra. Elena Lucrecia Silvera Carcache, MD, Family Doctor

Artemisa, Pedro Esperón Primary Care Unit, Dr. Mauricel Ortega Sánchez, MD, Family Doctor

Artemisa, José Hipólito Pasos Primary Care Unit, Dra. Susel Vilier Lores, MD, Family Doctor

Artemisa, Tomas Romay Primary Care Unit, Dra. Yaima de la Caridad Vázquez Torres, MD, Family Doctor

Matanzas, José Ramón López Tabranes Hospital, Dra. Kirenia Camacho, MD, First Degree Especilist in Oncology

Matanzas, José Luis Dubrocq Primary Care Unit , Dr. Poncio Blanco Mustelier, MD, Family Doctor

Matanzas, Carlos Juan Finlay Primary Care Unit, Dra. Yurier Acevedo Pérez, MD, Family Doctor

Matanzas, José Antonio Echevarría Primary Care Unit, Dra. Matilde Ugarte Hernández, MD, Family Doctor

Matanzas, Siete de Diciembre Primary Care Unit, Dra. Anisley Alvarez Gómez, MD, Family Doctor

Matanzas, Rene Vallejo Primary Care Unit, Dr. Ihosvanny E.Carreño Rolando, MD, Family Doctor

Matanzas, José Machado Primary Care Unit, Dra. Yaumara Martínez García, MD, Family Doctor

Cienfuegos, Hospital Gustavo Aldereguía, Dra. Yoana Herrera Leyva, MD, First Degree Especilist in Oncology

Cienfuegos, Manuel Fajardo Primary Care Unit, Dr. Rigoberto A. Hermida Acosta, MD, Family Doctor

Cienfuegos, Manuel Piti Fajardo Primary Care Unit, Dra. Milagros Ayo Pérez, MD, Family Doctor

Cienfuegos, Octavio de la Concepción y Pedraja Primary Care Unit, Dra. Gloria I. Lara Calderín, MD, Family Doctor

Cienfuegos, Laboral Area 7, Dra. Maritza Monzón Delgado, MD, Family Doctor

Sancti Espíritus, Camilo Cienfuegos Hospital, Dra. Niurelkys Fardales Rodríguez, MD, First Degree Especilist in Oncology

Sancti Espíritus, Sur Primary Care Unit, Dr. Lázaro Menéndez Pérez , MD, Family Doctor

Sancti Espíritus, Manuel de Jesús Lara Canteno Primary Care Unit, Dr. Julio Ugando, MD, Family Doctor

Sancti Espíritus, Carlos J Finlay, Dr. Ernel Gómez Cantero, MD, Family Doctor

Ciego de Ávila, Antonio Luaces Hospital, Dr. Loisel Bello Ulloa, MD, First Degree Especilist in Oncology

Ciego de Ávila, Roberto Rodríguez Hospital, Dra. Liannys Armas Espinosa, MD, First Degree Especilist in Oncology

Ciego de Ávila, Docente Norte Primary Care Unit, Dra. Odelaine Guzmán Pérez, MD, Family Doctor

Ciego de Ávila, Julio Castillo Primary Care Unit, Dra. Yudit de Corte Gutiérrez, MD, Family Doctor

Ciego de Ávila, Diego del Rosario Primary Care Unit, Dr. Olegario R. Sánchez Real, MD, Family Doctor

Ciego de Ávila, Juan Olimpo Varcárcel Primary Care Unit, Dra. Evelyn Sánchez Navarro, MD, Family Doctor

Ciego de Ávila, José Agustín Mas Naranjo Primary Care Unit, Dra. Maryoli Sánchez Smith, MD, Family Doctor

Ciego de Ávila, Mario Páez Inchausti Primary Care Unit, Dra. Yaiczat Torres Rojas, MD, Family Doctor

Ciego de Ávila, Raúl Ortiz Primary Care Unit, Dra. Eliuska Ramírez Martínez, MD, Family Doctor

Ciego de Ávila, Doña Emilia González Primary Care Unit , Dra. Liudmila Yumar Rodríguez, MD, Family Doctor

Camagüey, María Curie Hospital, Dra. Mónica Limia Pacheco, MD, First Degree Especilist in Oncology

Camagüey, Julio A Mella, Dra. Mabel Agramonte Cuan, MD, Family Doctor

Camagüey, Previsora Primary Care Unit, Dra. Arelys Guerra de la Vega, MD, Family Doctor

Camagüey, José Martí Primary Care Unit, Dra. María de los Ángeles Garrido Pérez, MD, Family Doctor

Camagüey, Joaquín de Agüero Primary Care Unit, Dr. Jorge Luis Purniel Rodríguez, MD, Family Doctor

Camagüey, C Agramonte, Dr. Lem Guzmán Matías, MD, Family Doctor

Guantánamo, Hospital Agostino Neto , Dra. Liuvia Vazquez Balart, MD, First Degree Especilist in Neumology

Guantánamo, Francisco Castro Primary Care Unit, Dra. Magdalis De La Cruz Camajuani, MD, Family Doctor

Guantánamo, Asdrúval López Vázquez Primary Care Unit, Dra. María del Carmen Martínez Rodríguez, MD, Family Doctor

Guantánamo, Ciro Frías Cabrera Primary Care Unit, Dra. Yoalis Matos Gamboa, MD, Family Doctor

Guantánamo, IV Congreso Primary Care Unit, Dra. Eliset Cobas Navarro, MD, Family Doctor

Guantánamo, Gilberto Isalgué Primary Care Unit, Dra. Yamilka Blanco Sarracent, MD, Family Doctor

Las Tunas, Hospital Ernesto Guevara, Dra. Elizabeth Pérez Velázquez, MD, First Degree Especilist in Oncology

Las Tunas, Romárico Oro Primary Care Unit, Dra. Belkis Teresa Villegas, MD, Family Doctor

Las Tunas, Guillermo Tejas Primary Care Unit, Dr. Ariel Labrada Salas, Clinician

Las Tunas, 7 de Noviembre Primary Care Unit, Dra. Idania Grau Martínez, MD, Family Doctor

Las Tunas, Gustavo Aldereguía Primary Care Unit, María Onella Silva Silva, MD, Family Doctor

Granma, Celia Sánchez Hospital, Dr. Conrado Luis Mustelier Rosales, MD, First Degree Especilist in Oncology

Granma, Carlos Manuel de Céspedes Hospital, Dr. Carlos Gonzáles, MD, First Degree Especilist in Oncology

Granma, Maximo Gómez Primary Care Unit, Dra. YenisNelsis Sánchez Cadrelo, MD, Family Doctor

Granma, Edor de los Reyes Primary Care Unit, Dra. Elisabeth Menéndez. Montoya, MD, Family Doctor

Granma, Jimmy Hirzell Primary Care Unit, Dra. Niurka Bencosme Rodríguez, MD, Family Doctor

Granma, Juan Enrique de la Paz Primary Care Unit, Dra. Lesyanis Tamaño Muñoz, MD, Family Doctor

Granma, Angel Ortiz Primary Care Unit, Dra. Zenaida Carbonell, MD, Family Doctor

Granma, Raúl Podia Saborit Primary Care Unit, Dra. Odalys Álvarez Suarez, MD, Family Doctor

Granma, Manuel Sánchez Silveira Primary Care Unit, Dr. Fernando Sánchez Torres, MD, Family Doctor

Granma, René Vallejo Primary Care Unit, Dr. Ernesto Yero Fonseca, MD, Family Doctor

Granma, Faustino Pérez Primary Care Unit, Dr. Ernesto Rafael Tamayo Pérez, MD, Family Doctor

Granma, Ernesto Guevara Primary Care Unit, Dr. Yobanis Ortiz Ceruto, MD, Family Doctor

Granma, Guillermo García Polanco Primary Care Unit, Dra. Liset Carrazana Rodríguez, MD, Family Doctor

Granma, Joel Benítez Primary Care Unit, José Jacinto Mosqueda Silva, MD, Family Doctor

Pinar del Río, III Congreso Hospital, Dra. Bárbara Iglesias Castillo, MD, Family Doctor

Pinar del Río, Ernesto Guevara Primary Care Unit, Dr. Dagoberto Quintana Mejías, MD, Family Doctor

Pinar del Río, Juan B Zayas Primary Care Unit, Dr. Deyli Miranda Prieto, MD, Family Doctor

Pinar del Río, José Elias Borges Primary Care Unit, Dra. Greidys Miranda Álvarez, MD, Family Doctor

Pinar del Río, Fermín Valdez Domínguez Primary Care Unit, Dra. María Cristina Valle Plasencia, MD, Family Doctor

Pinar del Río, Pedro Borras Primary Care Unit, Dr. Gustavo Hernández Díaz, MD, Family Doctor

Pinar del Río, Elena Fernández Castro Primary Care Unit, Dra. Ivet M. Rabelo Hernández, MD, Family Doctor

Pinar del Río, 5 de septiembre Primary Care Unit, Dra. Dianelis Martínez Rojas, MD, Family Doctor

Pinar del Río, Turcios Lima Primary Care Unit, Dr. Miguel Azcuy Ruiz, MD, Family Doctor

Pinar del Río, Hermanos Cruz Primary Care Unit, Dr. Guillermo L. Herrera Miranda, MD, Family Doctor

Pinar del Río, Epifanio Rojas Gil Primary Care Unit, Dra. Cruzmaida Reyes Sablón, MD, Family Doctor

Pinar del Río, Modesto Gómez Primary Care Unit, Dra. Mileidys Naranjo Rdguez, MD, Family Doctor

Pinar del Río, Manuel Piti Fajardo Primary Care Unit, Dr. Ricardo Braña Valdés, MD, Family Doctor

Santiago de Cuba, Juan Bruno Zayas Hospital, Dra. Justa Carmen Columbie Reguiferos, MD, First Degree Especilist in Oncology

Santiago de Cuba, Hospital Saturnino Lora, Dr. Leonardo Lobaina Lambert, MD, First Degree Especilist in Oncology

Santiago de Cuba, Camilo Torres Primary Care Unit, Dra. Isabel María Rosabal Rosas, MD, Family Doctor

Santiago de Cuba, Giraldo Aponte Primary Care Unit, Dra. Nadine Ariadna Ramos Silveira, MD, Family Doctor

Santiago de Cuba, Eduardo Mesa Primary Care Unit, Dra. Annia Chaveco Barcena, MD, Family Doctor

Santiago de Cuba, José Martí Primary Care Unit, Dra. Vivian Matos Trujillo, MD, Family Doctor

Santiago de Cuba, Carlos J Finlay Primary Care Unit, Dr. Eliécer Pérez Fuentes, MD, Family Doctor

Santiago de Cuba, Cruce de Los Baños Primary Care Unit, Dra. Yasmín Escalante Aliaga, MD, Family Doctor

Santiago de Cuba, Victoria de Girón Primary Care Unit, Dra. Mariluz Vazquez, MD, Family Doctor

Santiago de Cuba, América 1 Primary Care Unit, Dra. Dianelis Oliva Ramírez, MD, Family Doctor

Santiago de Cuba, Alberto Fernández Primary Care Unit, Dr. Leonardo Lobaina Lambert, MD, Family Doctor

Santiago de Cuba, Nestor López Cuba Primary Care Unit, Dr. Ricardo Díaz Galán, MD, Family Doctor

Santiago de Cuba, 30 de Noviembre Primary Care Unit, Dra. Elizabeth Dosil Bernal, MD, Family Doctor

Holguín, Vladimir Ilich Lenin Hospital, Dra. Migdalia Corella San Nicolás, MD, First Degree Especilist in Oncology

Holguín, Mario Gutiérrez Ardaya Primary Care Unit, Dr. Raúl Bermúdez Pino, MD, Family Doctor

Holguín, Máximo Gómez Báez Primary Care Unit, Dra. Maira Rojas Pérez, MD, Family Doctor

Holguín, José Ávila Serrano Primary Care Unit, Dr. Jorge Vega Abascal, MD, Family Doctor

Holguín, Mario muñoz Monroe Primary Care Unit, Dra. Kersting María Leyva Rojas, MD, Family Doctor

Holguín, Rolando Ricardo Estrada Primary Care Unit, Dra. Greisy Severina Súarez Gómez, MD, Family Doctor

Research ethics committees:

Celestino Hernandez Robau Hospital, July 28th, 2015

Ethic Comite of Santa Clara Municipality, August 19th, 2015 (Applied for the following primary care units: Chiqui Gomez, Santa Clara, XX Aniversario, Jose Ramon Leon Acosta, Marta Abreu, Roberto Fleites)

Primary care unit "Carlos M. Portuondo", September 17th, 2015

Primary care unit "Elpidio Berovides", October 8th, 2015

Primary care unit "Julio A. Mella", October 22th, 2015

Primary care unit " Lidia y Clodomira", October 19th, 2015

Primary care unit " Raul Gomez Garcia", October 29th, 2015

Miguel Enriquez, September 18th, 2015

Primary care unit "Luis Galvan", October 15th, 2015

Primary care unit "Federico Capdevila", October 8th, 2015

Primary care unit "Efrain Mayor' , September 26th, 2015

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

14/12/2015

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:

Advanced non small cell lung cancer (NSCLC)

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Intervention(s):

Experimental group: CIMAvax-EGF therapeutic vaccine. The vaccine will be administrated by intramuscular route, a dose of 2,4 mg. The first four doses (induction stage) will be administered every 14 days and the other doses (maintenance stage) every 28 days until the patient's clinical conditions allow. Prior to the first dose of the vaccine, immunomodulatory dose cyclophosphamide (200 mg / m2, will be administered by intravenous route

Intervention keyword:

CIMAvax-EGF vaccine

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):

Serious Adverse Event, expected or unexpected, with definite or probable causality relationship with the study product. Measuring time: monthly for two years.

Key secondary outcomes:

Security Related: Adverse Events (AE): Measuring time: inclusion and monthly for two years. Measured as: 1. Occurrence of any AE (yes, no) 2. Description of AE(name of adverse event). 3. Time of onset of AE(difference between start and completion of the EA) 4. Seriousness of AE (1. Serius, 2 No serious) 5. Intensity of AE (1. Light, 2. Moderate 3. Severe, 4. Very severe 5. Death) 6. Causality relationship (1.Very Likely/Safe/final, 2. Likely 3. Possible, 4. Unlikely 5. unrelated 6. Unknown) 7. Attitude followed by the appearance of AE (1. No change 2. Modification of dose 4. 3.Interrupción temporary or definitive interruption) 8. Result of the AE (1. Recovered, 2. Improved , 3. Persists or Consequences.) 9. Batch of vaccine CIMAvax-EGF® (Batch Number of the vaccine) -Hemoglobin (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18 and 24 months -White blood cell count with differential (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Hematocrit (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Platelets (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) (numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Glycemic (Nnumeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Bilirubin (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -Alkaline phosphatase (Numeric value according the system unit). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months Related effectiveness -Time Overall survival (time between inclusion and the date of death of the patient). Measuring time: at baseline, and monthly for two years. -Quality Of life (Questionnaires EORTC QLQ-C30 and EORTC QLQ-CC 13). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months -First-line treatment response (Complete response, Partial response, stable desease, Progesion, Not evaluable accoridng to RECIST version 1.1, 2009). Measuring time: at baseline

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 of either sex and greater than or equal to 18 years. 2. Patients who met the diagnostic criteria. 3. Non-eligible patients for chemotherapy or radiotherapy or who have received the treatment oncospecific available and have no other treatment option. 4. Patients who have signed informed consent for research. 5. Patients with clinical criteria status (ECOG) 0 to 3. 6. Patients with a life expectancy greater than or equal to 3 months.

Exclusion criteria:

1. Patients participating in another clinical trial. 2. Patients who have been treated with specific immunotherapy CIMAvax-EGF in the previous 6 months. 3. Patients who present a history of hypersensitivity to compounds similar to the vaccine or other component of the product formulation biological or chemical composition. 4. Patients of childbearing age who are not using an appropriate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). If male (vasectomy, condoms) during treatment 5. Patients who are pregnant, breastfeeding or postpartum. 6. Patients with brain metastases.

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:

Target sample size:

Patients to be recruited in 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:

Pedro

Middle Name:

Pablo

Last Name:

Guerra Chaviano

Specialty:

Industrial engineering, MSc. in Clinical Trials

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

5ta A,between 60 y 62 Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+5372164221

Email :

pedrop@cencec.sld.cu

pedropa@infomed.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:

Geidy

Last Name:

Lorenzo Monteagudo

Specialty:

BSc. in Farmaceutical Sciences, MSc. in Toxicology

Affiliation:

Center for Molecular Immunology

Postal Address:

216 Street and 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

16040

Telephone:

+5372717933

Email :

geydi@cim.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

741

Study completion date:

30/11/2021

Date of available results:

30/04/2022

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:

RPCEC00000205

Date of Registration in Primary Registry:

14/12/2015

Record Verification Date:

2021/08/27

Next update date:

2022/08/27

Link to the spanish version:

Click here

Ensayos Registrados

Proceso de Registro

CIMAvax-EGF vaccine Predictor Phase IV

Acerca del RPCEC

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