CIGB-370 in patients with malignant tumors

Phase 1

Completed

• Conditions: Malignant tumors; Neoplasms

• Registration Number: RPCEC00000209
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified