Revisions for EC122 HER-1 Prostate Phase I | Registro Público Cubano de Ensayos Clínicos

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Revision of 21 November 2016 - 4:58pm:

EC122 HER-1 Prostate Phase I

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:

HER-1 CPRC

Scientific title:

Phase I clinical trial of the HER-1 vaccine in patients with prostate tumors of epithelial origin.

Acronym of Scientific Title:

EC FI HER-1 CPRC

Secondary indentifying numbers:

EC122

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology

Source(s) of monetary or material support:

State reserve (government funds)

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)

Authorization date :

26/08/2009

Reference number:

05.017.09.B

Principal investigator

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

First name:

Javier

Last name:

Rivero Ojeda

Medical Specialty :

Specialist 2nd Grade in Urology

Affiliation:

Medical Surgical Research Center

Postal address:

216 Street between 13 and 15. Siboney

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-78581000

+53-78581100

Email address:

rojeda@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:

Havana, Hermanos Ameijeiras Hospital, Joaquín González González, Specialist II degree in Clinical Oncology

Research ethics committees:

Medical Surgical Research Center, October 6th, 2008

Hermanos Amejeiras Hospital, September 6th, 2010

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

23/10/2009

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:

Hormone refractory prostate cancer

Health condition(s) code:

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Urogenital Diseases, Male

Prostatic Diseases

Intervention(s):

Group I (Experimental): HER-1 dose 100 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168. Group II (Experimental): HER-1 dose 200 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168. Group III (Experimental): HER-1 dose 400 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168. Group IV (Experimental): HER-1 dose 600 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168. Group V (Experimental): HER-1 dose 800 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168

Intervention code:

Receptor, Epidermal Growth Factor

Vaccines

Immunization

Injections, Intramuscular

Intervention keyword:

HER-1

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):

Toxicity of the vaccine preparation with human HER-1 - Adverse Events (AE) measured at days 0, 56, 84, 112, 140, 168, 196, 224, 252, 280, 308 and 336. The AE will be measured as: - AE name (Description of the AE) - AE intensity (Light, Moderate, Severe, Very severe, Death related to the adverse event) - Causality relationship (Definitive, Very likely, Probable, Possible, Not related) - Treatment applied (None, medication, surgical procedure, Transfusion, Others) - Result of the treatment applied to counteract the EA (Recovered, Continue, Unknown, Death due to the adverse event)

Key secondary outcomes:

Immunogenicity of the vaccine HER-1 Antibody titer (concentration of polyclonal anti-HER-1 in the blood). Measuring time: 0, 56, 84, 112, 140, 168, 196, 224, 252, 280 and 308 days

Selection criterias

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

Gender:

Male

Minimum age:

40 years

Maximum age:

None

Inclusion criteria:

1. Patients who meet the diagnostic criteria. 2. Patients with greater than or equal to 40 years age. 3. Patients who have signed informed consent. 4. Patients with overall as less than 2 ECOG. 5. Patients with longer life expectancy of 6 months. 6. Patients with functioning of organs and bone marrow, defined by the following parameters: - Hemoglobin greater than or equal to 90 g / l - White blood cell count, greater than or equal to 3.0 x 109 leucocytes / L - Absolute Neutrophil Count, greater than or equal to 1.5 x Neutrophil 109 / L - Platelets greater than or equal to 100 x 109 platelets / L - Bilirubin values within normal limits of the institution. (0 to 17 micromol / L). - TGO/TGP less than or equal to 2.5 times the upper limit of the normal range in the institution. - Creatinine values within normal limits of the institution. (35-135 micromol / L)

Exclusion criteria:

1.Patients receiving other onco-specific investigational product. 2.Patients with uncontrolled intercurrent illness including: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, liver damage and psychiatric illness that may limit adherence to clinical trial requirements. 3. Patients with brain metastases. 4. Patients with compromised immune systems, including current disease or history of eczema, atopic dermatitis, autoimmune disease (autoimmune neutropenia, thrombocytopenia, hemolytic anemia, HIV, lupus erythematosus, Sjogen syndrome, scleroderma, myasthenia gravis "Goodpasture" syndrome, Addison's disease, Hashimoto's thyroiditis, Graves' disease). 5. Allergic patient to any component of the formulation.

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:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Sequential

Phase:

1

Target sample size:

25

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:

Angel

Middle Name:

Raimundo

Last Name:

Casaco Parada

Specialty:

Specialist 2nd Grade in Normal and Pathological Physiology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 Street and 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72717933

Email :

casaco@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:

Angel

Middle Name:

Raimundo

Last Name:

Casaco Parada

Specialty:

Specialist 2nd Grade in Normal and Pathological Physiology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 Street and 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537-2717933

Email :

casaco@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:

RPCEC00000219

Date of Registration in Primary Registry:

15/11/2016

Record Verification Date:

2016/11/21

Next update date:

2017/11/21

Link to the spanish version:

Click here

Registered Trials

Registration process

EC122 HER-1 Prostate Phase I

About the RPCEC

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