Evaluation of the safety and pharmacokinetics and determining the maximum tolerable dose with the use of antitumor peptide CIGB-552 in solid tumors. Phase I.

Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点开始时间: 2015年5月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Other. Purpose: Treatment

•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.

发起方

Center for Genetic Engineering and Biotechnology (CIGB)