CIGB-370 in patients with malignant 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:

POLITUR-2

Scientific title:

CIGB-370 administration in malignant tumors . Repeated dose study, dose escalation.

Secondary indentifying numbers:

IG/CIGB-370I/TM/1302

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana Ministry of Public Health, CUBA.

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 Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

11/01/2016

Reference number:

05-006-14-BA

Principal investigator

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

First name:

Maylin

Last name:

Jiménez Abraham

Medical Specialty :

Fisrt degree specialist in Oncology

Affiliation:

Universitary hospital "Gustavo Aldereguia Lima"

Postal address:

Avenida 5 de Septiembre, esquina A calle 51A.

City:

Cienfuegos

País:

Cuba

Zip Code:

10400

Telephone:

+53-458382578

Email address:

direccion@gal.sld.cu [1]

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, University Hospital "Celestino Hernández", Acralys Garabito Perdomo, 1st Degree Specialist in Oncology.

Havana, Medical Surgical Research Center, Javier Figueredo Méndez, 2nd Degree Specialist in Neurosurgery.

Research ethics committees:

Universitary Hospital “Gustavo Aldereguía Lima”, December 20, 2013.

University Hospital "Celestino Hernández", March 15, 2016.

Medical Surgical Research Center, April 18, 2016.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

16/05/2016

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:

Malignant tumors

Health condition(s) code:

Neoplasms

Intervention(s):

Group I (experimental): CIGB 370 at dose of 1.85mg/m2. The product will administer at intravenously infused over 1 hour, twice a week for 4 weeks (8 administrations in total). Group II (experimental): CIGB 370 at dose of 3.7mg/m2. The product will administer at intravenously infused over 1 hour, twice a week for 4 weeks (8 administrations in total). Group III (experimental): CIGB 370 at dose of 6.1mg/m2. The product will administer at intravenously infused over 1 hour, twice a week for 4 weeks (8 administrations in total).

Intervention code:

Peptides

Intervention keyword:

polypeptide, CIGB-370

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):

Clinical Adverse Events (AE). Measuring time: week 1, when initiating the administration of anti-tumor candidate CIGB-370, before each administration (during the first 4 weeks of treatment) and at weeks 5 to 8. The adverse events will be measured like: -Appearance of AE (Yes, No) -Description of AE (name of the event) -Intensity of EA (mild, moderate, severe) Laboratory tests (numerical values of hematology and biochemistry). Measuring time: at baseline, week 5, and week 8.

Key secondary outcomes:

Pharmacokinetics of CIGB-370 polypeptide (i n serum). Measuring time: before administration CIGB-370, at 15 and 30 minutes post-infusion i n hours 1, 2, 3, 5, 7, 12, 16, 24, 36 and 48, and on days 7, 15, 21 and 28 post-treatment initiation. Immune response (titer determination of anti-bodies anti -CIGB370). Measuring time: Days 7, 15, 21 and 28. Identifying target polypeptide CIGB-370 tumor markers (plasma, qualitatively by co-immunoprecipitation method). Measuring time: at baseline, week 8. Quality of life (EORTC QLQ-C30 survey: worsened, unchanged, slightly improved, moderately improved, and much improved). Measuring time: at baseline, week 8. Tumor response (RECIST version 1.1: Complete response, Partial response, Stable Disease, Progressive disease). Measuring time: week 8.

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:

65 years

Inclusion criteria:

1. Compliance with the diagnostic criteria (histological diagnosis of a malignant tumor from any location, solid or hematopoietic, advanced clinical stage, they are not eligible for other therapeutic procedures). 2. Age between 18-65 years inclusive. 3. Patient with a life expectancy ≥ 6 months. 4. According to ECOG performance status ≤ 2. 5. Voluntariness of the patient by signing the informed consent.

Exclusion criteria:

1. Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 2. Moderate or severe systemic infections that interfere with patient evaluation. 3. Have received chemoradiotherapy in the past 4 weeks. 4. Patients who have received any investigational biological therapy or are involved in a clinical trial. 5. History of chronic liver disease (chronic hepatitis, liver cirrhosis and hepatocellular carcinoma). 6. History of cancer in situ of the uterine cervix. 7. History of allergy to any ingredient of the product under consideration. 8. Pregnancy or breastfeeding at the time of inclusion in the study. 9. Mental incapacity evident to issue consent and act accordingly to the study. 1. Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 2. Moderate or severe systemic infections that interfere with patient evaluation. 3. Have received chemoradiotherapy in the past 4 weeks. 4. Patients who have received any investigational biological therapy or are involved in a clinical trial. 5. History of chronic liver disease (chronic hepatitis, liver cirrhosis and hepatocellular carcinoma). 6. History of cancer in situ of the uterine cervix. 7. History of allergy to any ingredient of the product under consideration. 8. Pregnancy or breastfeeding at the time of inclusion in the study. 9. Mental incapacity evident to issue consent and act accordingly to the study.

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:

Other

Other design:

Dose escalation

Phase:

Target sample size:

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:

Idania

Last Name:

Baladrón Castrillo

Specialty:

2nd Degree Specialist in Gynecology

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, (53-7)-2087465

Email :

idania.baladron@cigb.edu.cu [2]

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:

Maria

Middle Name:

del Carmen

Last Name:

Abrahantes Pérez

Specialty:

PhD in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2504647

Email :

mc.abrahantes@cigb.edu.cu [3]

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:

RPCEC00000209

Date of Registration in Primary Registry:

01/02/2016

Record Verification Date:

2018/07/31

Next update date:

2019/07/31

Link to the spanish version:

Click here [4]