hR3 in metastatic or recurrent colorectal cancer

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 Nimotuzumab (hR3) mAb as Monotherapy in patients with metastatic or recurrent colorectal cancer.

Secondary indentifying numbers:

IIC RD-EC 134

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Cuban Health Ministry (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)

Authorization date :

28/02/2011

Reference number:

05.002.11.B

Principal investigator

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

First name:

Mayte

Last name:

Lima

Medical Specialty :

MD, First degree specialist in Oncology

Affiliation:

Hospital "Hermanos Ameijeiras"

Postal address:

San Lázaro No. 701 esquina a Belascoaín

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761926

Email address:

mayte.lima@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:

Hermanos Ameijeiras Surgical Clinical Hospital, September 6, 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:

27/05/2011

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:

Metastatic or recurrent colorectal cancer

Intervention(s):

Group I (Experimental): Nimotuzumab (hR3) 200 mg. Grupo II (Experimental): Nimotuzumab (hR3) 400 mg. Grupo III (Experimental): Nimotuzumab (hR3) 800 mg. Grupo IV (Experimental): Nimotuzumab (hR3) 1200 mg. Nimotuzumab Indication: weekly, for 7 weeks then every 2 weeks (intravenous infusion) by 24 month or until significant toxicity.

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):

Incidence of Adverse Events (AE) relating to the administration of Nimotuzumab (AE with causal relationship probable or very likely). Measuring time: in every administration until to complete 2 years of treatment. • Type of AE (name of the adverse event) • Duration of AE (Difference between of start date and the end date of the AE. May be in days, hours or minutes) • Intensity of AE (mild, moderate, severe, Life threatening, death related) • Serious AE (Severe/Serious, not serious/not serious) • Attitude from study treatment (unchanged, dose modification, temporary discontinuation of study treatment, permanent discontinuation of study treatment) • Result of AE (recovered, improved, persist, sequelae) • Causality of the adverse event (Certain, Probable /Likely, Possible, Unlikely, Unrelated)

Key secondary outcomes:

Clinical Response (Objective response and Antitumor Clinical Response). Objective response (Measurable disease and No measurable disease). Measuring Time: every 3 months until to complete 2 years of treatment. - Measurable disease (Complete Response, Partial Response, No change, Progression) - No measurable disease (Complete Response, Partial Response, Stabilization, Progression) Antitumor Clinical Response(Complete Response, Partial Response, Progressive Disease, Stable disease). Measuring Time: every 3 months until to complete 2 years of treatment. Progression-free survival (PFS). Time in months from inclusion date until it objectively documented progressive disease or death. Measuring time: 2 years of treatment or progression date or death date. Global Survival. Time in months from the inclusion date until death or last date you have news. Measurement time: 2 years of treatment or death. EGFR expression (High, Moderate, Low, Negative). Measurement time: Before the treatment. KRAS expression (Mutated, Unmutated). Measurement time: Before the treatment.

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 with colorectal cancer diagnosed after received at least one chemotherapy regimen with oxaliplatin 2. Age greater than or equal to 18 years, of any gender or skin color 3. Patients with at least one measurable metastatic lesion, defined as those than can be measured using imaging techniques (CAT and/or NMR), before first line CT (as RECIST criteria, version 1.1). 4. Patients could have received chemotherapy, provided that such treatment had ended, at least, 4 weeks before being included in the study. 5. General status ECOG 0-2 6. Life expectancy of at least 12 weeks. 7. Patients comply with the requirements of the clinical laboratory: haemoglobin> 9 g/L, ALC >3 x 109 cells/L, platelets > 100 x 109/L, ANC≥ 1,5x109 /L, bilirubin <17 µmol/L, creatinine < 132 µmol/L, TGO/TGP<2.5 time upper normal limits. 8. Able and willing to give written informed consent.

Exclusion criteria:

1.Patients with uncontrolled intercurrent illness including: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and psychiatric or social conditions that may limit adherence to clinical trial requirements. 2. Presence of brain metastasis. 3. Pregnancy or breastfeeding, or patients who refuse to use contraception during the study. 4. Patients that are receiving another investigational product. 5. Patients with history of hypersensitivity to this or any other similar biological product. 6. Patients previously treated with Monoclonal Antibodies.

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:

1

Target sample size:

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:

Patricia

Last Name:

Hernandez Casanna

Specialty:

PhD, Clinical Researcher Promoter

Affiliation:

Center of Molecular Immunology

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600, PO Box 16040

Telephone:

+537-214-3145

Email :

patriciahc@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:

Patricia

Last Name:

Hernandez Casanna

Specialty:

PhD, Clinical Researcher Promoter

Affiliation:

Center of Molecular Immunology

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600, PO Box 16040

Telephone:

+537-214-3145

Email :

patriciahc@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:

RPCEC00000175

Date of Registration in Primary Registry:

22/11/2013

Record Verification Date:

2013/11/06

Next update date:

2014/11/06

Link to the spanish version:

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Proceso de Registro

hR3 in metastatic or recurrent colorectal cancer

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