TS-FARMEV Study

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:

Safety clinical trial and pharmacological evaluation of intravenous administration of CIGB-300 in patients with solid tumors refractory to oncospecific treatment.

Secondary indentifying numbers:

IG/CIGB-300 I/TS/0901

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

HeberBiotec S.A. Biorec S.A.

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 :

26/02/2010

Reference number:

05.036.09.B

Principal investigator

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

First name:

Jorge Luis Soriano García MD. 2nd grade Specialist in Oncology. Noyde Batista Albuerne MD. 1st grade Specialist in Oncology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [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:

Havana, Clinical Research Center, Caridad Alina Casacó Santana MD. 1st grade Specialist in Imagenology. Havana, Center of Medical and Surgical Research (CIMEQ), Josué de la Torre Pupo MD. 1st grade Specialist in Oncology. Villa Clara, Universitary Hospital “Celestino Hernández Robau”, Julio Orlando Hernández MD. 1st grade Specialist in Oncology.

Research ethics committees:

Havana, Clinical - Surgical Hospital "Hermanos Ameijeiras", December 7, 2009. Havana, Clinical Research Center, December 4, 2009. Havana, Center of Medical and Surgical Research (CIMEQ), February 21, 2011. Villa Clara, Universitary Hospital “Celestino Hernández Robau”, February 18, 2011.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

07/06/2010

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:

Solid tumors refractory to oncospecific treatment.

Intervention(s):

It CIGB-300 administered intravenously using a dose-finding design sequentially, based on a continuous reallocation method of dose escalation. The doses to be studied will be: - 0.2 mg/kg - 0.4 mg/kg - 0.8 mg/kg - 1.6 mg/kg We will start with an initial dose of 0.2 mg / kg up to the maximum tolerated dose (MTD) of the study. Patients will receive 3 cycles of IGBC-300 with daily treatments for 5 days on weeks 1, 3 and 5. Patient will receive Diphenhydramine 1 ampoule (50 mg) and Hydrocortisone 1 bulb (100 mg) intravenously 30 minutes before receiving the dose of IGBC-300 question.

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):

Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: days or hours; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: 30 minutes and hour, 2, 4, 8 and 12 hours after administration of each dose of CIGB-300. Percent maximum uptake (maximum percentage is the fraction of injected activity that is captured or incorporated by an organ or tumor and is determined as: Activity (tmax) * 100/Actividad Injected, where tmax is the time it reaches the maximum incorporation). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Fraction of incorporation (is the total fraction of injected activity that is incorporated into an organ or tumor and is determined as total activity incorporated / injected activity). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Fraction of elimination (total fraction of injected activity that is eliminated by an organ or tumor and is determined as total activity eliminated / injected activity). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Average time biological uptake (is the average time that the activity taken to an organ or tumor increases to half of its value and is determined as: ln (2)/k, where k is the constant of biological incorporation). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Average time biological removal (is the average time that the activity taken to an organ or tumor decreased to half its value and is determined as: ln (2)/k where k is the biological elimination constant). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose.

Key secondary outcomes:

Evaluation of tumor response, if necessary through imaging tests (tumor diameter). Measuring time: 45 days after treatment ended, and every 3 months until the year into the study.

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:

75 years

Inclusion criteria:

1) Histological diagnosis of a solid tumor refractory to treatment oncospecific. 2) That the patient did not receive more than 2 lines of chemotherapy. 3) last cycle of chemotherapy 4 to 8 weeks after treatment ends oncospecific. 4) Age between 18-75 years inclusive. 5) Written consent from the patient.

Exclusion criteria:

1) Pregnancy and lactation 2) decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy, severe mental depression). 3) moderate or severe systemic infections that interfere with patient evaluation. 4) Patients with previous diagnosis of bleeding disorders and other chronic decompensated hematopatías (hemophilia, leukemia, etc.). 5) Values ??in clinical laboratory evaluations were normal limits prior to the start of treatment: 6) referred immunosuppressive disease, current drug intake immunosuppressive / immunomodulatory properties. 7) Autoimmune diseases (lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and previous severe allergic urticaria, dermatitis, bronchitis, bronchial asthma and persistent. 8) diseases that compromise the patient's consciousness or his ability to give informed consent or cooperate in the trial. 9) Have been included in another trial in the last 8 weeks.

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:

14 - 20

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:

Dr. Lidia

Last Name:

González Méndez

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

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

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

lidia.gonzalez@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:

Dr. Idania

Last Name:

Baladron Castrillo

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

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

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

idania.baladron@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:

RPCEC00000112

Date of Registration in Primary Registry:

2011-05-16

Record Verification Date:

2011-04-29 20:00

Link to the spanish version:

Click here [4]