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Nimotuzumab cold kit for the immunodiagnosis of solid tumors
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5 Octubre 2018 - 8:50am
por Gladys
21 Diciembre 2020 - 11:23am
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Revisión de 21 Diciembre 2020 - 11:23am
Nimotuzumab cold kit for the immunodiagnosis of solid tumors
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.
Acronym of Public Title:
Nimo kit
Scientific title:
Efficacy and safety of cold kit of monoclonal antibody nimotuzumab labeled with 99mTc for the immunodiagnosis of head and neck tumors, lung and gliomas
Acronym of Scientific Title:
Nimo cold kit
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Center of Molecular Immunology (CIM)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Center for 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:
Center for State Control of the Quality of Drugs(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:
Juan
Midle name:
Felipe
Last name:
Batista Cuellar
Medical Specialty :
1st Degree Specialist in Internal Medicine. Nuclear Physician.
Affiliation:
Isotope Center (CENTIS) - Clinical Research Center (CIC)
Postal address:
Street 45, number 4501, corner to 34, Kholy
City:
Havana
País:
Cuba
Zip Code:
11300
Telephone:
+53-72030087
+53-72023763
+53-72027055
Email address:
batista@infomed.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:
Not applicable
Research ethics committees:
Clinical Research Center (CIC), 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:
30/09/2019
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:
Tumors of head and neck, lung and gliomas
Health condition(s) code:
Head and Neck Neoplasms
Lung Neoplasms
Glioma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Neuroepithelia
Neoplasms, Glandular and Epithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Intervention(s):
Group I- MAb Nimotuzumab 3mg (Experimental). Immunoscintigraphy with the radioimmunoconjugate 99mTc-hR3 (3 mg of the Monoclonal Antibody Nimotuzumab from the cold kit, marked with 35-40 mCi of 99mTc) by intravenous route. Group II – MAb Nimotuzumab 6mg (Experimental). Immunoscintigraphy with the radioimmunoconjugate 99mTc-hR3 (6 mg of Nimotuzumab Monoclonal Antibody from the cold kit, labeled with 35-40 mCi of 99mTc) by intravenous route.
Intervention code:
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Radionuclide Imaging
Immunoscintigraphy
Immunologic Tests
Radioimmunodetection
Immunoconjugates
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):
1. Degree of graphic gamma positivity (InGG immunography will be performed to determine the degree of concordance, sensitivity, specificity, positive predictive value, negative predictive value). Measurement time: at 4 and 18-24 hours after the administration of Radioimmunoconjugate. 2. Overexpression of the EGFR (overexpression of EGFR in the biopsy as High, Moderate, Low, Negative). Measurement time: At baseline.
Key secondary outcomes:
Adverse events (Incidence of Adverse Events (AE) reported by the patient and by laboratory tests measured as: Occurrence of any AE (Yes, No); Description of the AE (Name of the adverse event); Duration of the AE (Difference between the start and end date of the AE); Intensity of the AE (Light, Moderate, Severe, AE that threatens or incapacitates and AE that causes death); Severity of the AE (Serious, Not serious); Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or squeal], Causal relationship (1. Definitive 2. Very probable, 3. Probable, 4. Possible, 5. Unrelated 6. Unknown)). Measurement time: 28 days after administration
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 have signed the informed consent. 2. Patients that meet the diagnostic criteria. 3. Patients with biopsy samples that allow IHC study of overexpression of EGFR, imaging study and clinical documentation to corroborate the existence of the lesions. 4. Patients of both sexes older than 18 years. 5. Patients with life expectancy of 3 months or more. 6. Patients with functional status according to the ECOG scale ≤ 2, (Eastern Cooperative Oncology Group) ECOG. 7. Patients with functioning of organs and bone marrow defined by the following parameters: Hemoglobin greater than or equal to 90 g / L. Total leukocyte count greater than or equal to 3.0 x 109 / L Platelet count greater than or equal to 100 x 109 / L. Bilirubin: Within normal limits for each institution Glycemia Within normal limits for each institution ALP: up to 2.5 times the normal upper limit for each institution. LDH: Within normal limits for each institution GOT/GPT: up to 2.5 times the normal upper limit for each institution. Creatinine: Within normal limits for each institution.
Exclusion criteria:
1. Patients with acute allergic states, history of severe allergic reactions or autoimmune diseases. 2. Patients who are receiving another product under investigation. 3. Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the monoclonal antibody. 4. Patients with uncontrolled intercurrent diseases, including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illnesses that could limit adherence to trial requirements. 5. Female patients who are pregnant, nursing.
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:
Diagnostic
Allocation:
Non-randomized controlled trial
Masking:
Open
Control group:
Uncontrolled
Study design:
Other
Other design:
Dose escalation
Phase:
1-2
Target sample size:
26-30
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:
Mayelin
Last Name:
Troche Concepcion
Specialty:
MSc. Clinical Trials, Bachelor's degree in nursing
Affiliation:
Center of Molecular Immunology (CIM)
Postal Address:
216th & 15th Ave., Atabey, Playa
City:
Havana
País:
Cuba
Zip Code:
16040, Box 11600
Telephone:
+53-72143144
Email :
mayelin@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:
Mayelin
Last Name:
Troche Concepcion
Specialty:
MSc. Clinical Trials, Bachelor's degree in nursing
Affiliation:
Center of Molecular Immunology (CIM)
Postal Address:
216th & 15th Ave., Atabey, Playa
City:
Havana
País:
Cuba
Zip Code:
16040, Box 11600
Telephone:
+53-7214 3144
Email :
mayelin@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:
RPCEC00000290
Date of Registration in Primary Registry:
05/10/2018
Record Verification Date:
2020/12/21
Next update date:
2021/12/21
Link to the spanish version:
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