Safety and pharmacokinetics of CIGB-552
- Conditions
- Solid tumors
- Registration Number
- RPCEC00000196
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1) Age =18 years.
2) Patients who meet the diagnostic criteria.
3) Values normal blood glucose values according institucionales.l
4) General status ECOG 0-2.
5) Patients who have normal functioning of organs and bone marrow defined by the following parameters:
- Haemoglobin = 9 g / L.
- Leukocytes = 3 x 109 / L.
- Absolute neutrophil count = 1.5 x 109 / L.
- Platelet count = 150-250 x 109 / L.
- Total bilirubin: Within normal limits as institutional values.
- TGP and TGO = 2.5 times the institutional upper limit of normal.
- Creatinine: Within normal limits as institutional values.
6) Voluntary patient by signing the informed consent model.
7) Life expectancy greater than 3 months.
1) Patients who are of childbearing potential not using adequate contraceptive method (IUDs, barrier methods, hormones or tubal ligation) for men (vasectomy, condom use) prior to their inclusion in the study and / or while participating in the clinical trial.
2) Patients with a positive pregnancy test, breastfeeding and postpartum women.
3) Patients suffering from severe allergic diseases.
4) diabetic patients.
5) That have been treated with other biological therapy six months preceding the date of inclusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events of intensity III and IV (Common Toxicity Criteria (Common Toxicity Criteria) (CTC) version 4.0 of the National Cancer Institute USA). Measuring time: after each administration, four weeks after the last administration of the product and at 12 weeks after inclusion.
- Secondary Outcome Measures
Name Time Method