Nimotuzumab-pancreatic cancer-adults-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:

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

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) 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:

In process

Principal investigator

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

First name:

Yamilka

Last name:

Sanchez Azcuy

Medical Specialty :

1st Grade Specialist of Oncology

Affiliation:

Center for Cancer Patient Care "III Congreso"

Postal address:

Street second apartment 16 B between 5th and B, Neighborhood "Ceferino Fernandez".

City:

Pinar del Rio

País:

Cuba

Zip Code:

20100

Telephone:

+53-048768460

Email address:

yamilka72@princesa.pri.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:

Artemisa, Hospital “Comandante Pinares”, Humberto Gamez Oliva, MD. 1st Grade Specialist of Oncology

Cienfuegos, Hospital “Gustavo Aldereguia Lima”, Luis A. Varona Vazquez, MD. 1st Grade Specialist of Oncology and Radiotherapy

Sancti Spiritus, Hospital “Camilo Cienfuegos Gorriaran”, Martha Lidia Concepcion Perez, MD. 1st Grade Specialist of Oncology

Ciego de Avila, Hospital “Antonio Luaces Iraola”, Odalis Arguelles, MD. 1st Grade Specialist of Oncology

Camaguey, Hospital “Manuel Ascunce Domenech”, Rene Rabasa Perez, MD. 1st Grade Specialist of Gastroenterology

Las Tunas, Hospital “Ernesto Guevara”, Jackeline de La Caridad Ruiz Diegues, MD. 1st Grade Specialist of Oncology

Santiago de Cuba, Hospital “Saturnino Lora”, Milenis Latereaux Cos, MD. 1st Grade Specialist of Oncology

Holguín, Hospital “Vladimir Ilich Lenin”, Ariel Leyva Pupo, MD. 1st Grade Specialist of Oncology

Granma, Hospital “Carlos Manuel de Cespedes”, Yoel Mario Ricardo Serrano, MD. 1st Grade Specialist of Oncology

Guantánamo, Hospital “Agostino Neto”, Angel Piriz Momblant, MD. 2nd Grade Specialist of General Surgery

Villa Clara, Hospital “Celestino Hernandez Robau”, Diovanis Hernandez Plasencia, MD. 1st Grade Specialist of Oncology

Havana, Hospital Center for Surgical Medical Research (CIMEQ), Sheyla Nora Vara, MD. 1st Grade Specialist of Oncology

Research ethics committees:

Center for Cancer Patient Care "III Congreso", 28/02/17

Hospital “Comandante Pinares”, in review

Hospital “Gustavo Aldereguia Lima”, in review

Hospital “Camilo Cienfuegos Gorriaran”, in review

Hospital “Antonio Luaces Iraola”, 01/03/2017

Hospital “Manuel Ascunce Domenech”, 28/02/2017

Hospital “Ernesto Guevara”, 27/02/2017

Hospital “Saturnino Lora”, in review

Hospital “Vladimir Ilich Lenin”, in review

Hospital “Carlos Manuel de Cespedes”, in review

Hospital “Agostino Neto”, in review

Hospital “Celestino Hernandez Robau”, 24/02/2017

Hospital Center for Surgical Medical Research (CIMEQ), in review

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/05/2017

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:

Pancreatic cancer locally advanced unresectable or metastatic

Health condition(s) code:

Pancreatic Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Digestive System Diseases

Pancreatic Diseases

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.

Intervention code:

Antibodies, Monoclonal, Humanized

Capecitabine

Fluorouracil

Leucovorin

Antineoplastic Agents

Drug Therapy, Combination

Antibodies, Monoclonal

Infusions, Intravenous

Administration, Intravenous

Administration, Oral

Intervention keyword:

Nimotuzumab Gemcitabine

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 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.

Key secondary outcomes:

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

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 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

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:

Patient to be recruited during two years. Ideal value: at least 136

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:

Ana

Middle Name:

Rosa

Last Name:

Valls Hung

Specialty:

Bachelor degree in Pharmaceutical Sciences

Affiliation:

Center of Molecular Immunology

Postal Address:

216 and 15, Street. Atabey. Playa.

City:

Havana

País:

Cuba

Zip Code:

16040

Telephone:

+53-72717933 ext 3491

Email :

ana@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:

Yamilka

Last Name:

Sanchez Azcuy

Specialty:

1st Grade Specialist of Oncology

Affiliation:

Center for Cancer Patient Care "III Congreso"

Postal Address:

Street second apartment 16 B between 5th and B, Neighborhood "Ceferino Fernandez".

City:

Pinar del Rio

País:

Cuba

Zip Code:

20100

Telephone:

+53-048768460

Email :

yamilka72@princesa.pri.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:

RPCEC00000245

Date of Registration in Primary Registry:

30/04/2017

Record Verification Date:

2017/04/30

Next update date:

2018/04/30

Link to the spanish version:

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Proceso de Registro

Nimotuzumab-pancreatic cancer-adults-Phase IV.

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