Status:
UNKNOWN
Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
Lead Sponsor:
CureLab Oncology
Conditions:
Ovarian Cancer
Platinum-resistant Ovarian Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Phase II, two arm prospective study of efficacy and safety of ELENAGEN in combination with gemcitabine in comparison with gemcitabine alone in patients with platinum-resistant ovarian cancer.
Detailed Description
The purpose of this clinical study is to evaluate safety and efficacy of ELENAGEN, a novel anticancer therapeutics (plasmid DNA encoding p62/SQSTM1) protein, as an adjuvant to chemotherapy with Gemcit...
Eligibility Criteria
Inclusion
- The patient is 18-70 years old.
- Written informed consent of the patient to participate in clinical trials.
- Presence of histologically confirmed ovarian cancer.
- The return of the disease occurred less than 6 months after the last administration of platinum.
- Presence of measurable tumor lesions according to RECIST 1.1 criteria.
- Functional status according to ECOG scale is 0-2.
- Life expectancy of at least 6 months.
- Adequate function of the organs as determined by the following criteria:
- Absolute number of neutrophils (ANN) ≥1500/mm3 (≥1.5 × 109/l);
- Platelet count ≥100,000/mm3 (IU: ≥100 × 109/l).
- Hemoglobin level ≥ 9.0 g/dL determined by analysis performed at least 2 weeks after the last hemotransfusion;
- The level of AST and ALT in blood serum not exceeding more than 3 times the upper limit of the norm.
- The level of serum bilirubin not exceeding more than 1.5 times the upper limit of normal.
- Serum Creatinine ≤ 1.5 mg/dL.
- The ability of the patient to follow the directions of the research physician and follow the study regimen.
Exclusion
- Criteria by which patients are not included in the study
- Platinum-sensitive relapse of ovarian cancer (disease recurrence occurred more than 6 months after the last administration of platinum drugs).
- Presence of serious diseases or health conditions:
- Other malignancies, with the exception of malignancies treated more than 5 years ago without signs of return of the disease.
- Brain metastases or leptomeningeal metastases.
- Active infection (e.g. fever ≥38 °C), including active or unresolved pneumonia/pneumonitis.
- Uncontrolled diabetes mellitus.
- Myocardial Infarction in the last 12 months, severe/unstable angina, clinically manifested heart failure class III-IV according to the classification of the New York Cardiology Association (NYCA).
- Gastrointestinal bleeding within the last 2 weeks.
- Human immunodeficiency virus (HIV), chronic or acute hepatitis B or hepatitis C.
- Patients with autoimmune disorders or organ transplantation who require immunosuppressive therapy.
- I. Mental illness that may increase the risk associated with participation in the study or taking the study drug or that may affect the interpretation of the results of the study.
- K. Polyallergy, bronchial asthma (including aspirin) in history.
- Major surgery during the previous 4 weeks (complete wound healing).
- Previous chemotherapeutic treatment of the patient according to the scheme GEMCITABINE
- Radiotherapy with extended field radiation within the previous 4 weeks or radiotherapy with a limited field radiation within the previous 2 weeks.
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05979298
Start Date
November 15 2019
End Date
December 30 2024
Last Update
August 7 2023
Active Locations (1)
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1
Minsk City Clinical Oncology Center
Minsk, Belarus