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Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

Open Label Randomized Clinical Study of Plasmid Encoding p62/SQSTM1 (ELenagen) in in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

NCT05979298•CureLab Oncology

View on ClinicalTrials.gov

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 Gemcitabin (GEM) in patients with advanced platinum-resistant ovarian cancer. This is a prospective randomized multi-center study with two arms. Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks) is administered in both arms: In the Chemo arm (n = 20) Gemcitabine is the only treatment, and in the ELENAGEN arm (n = 20) GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly). The primary endpoint is progression-free survival (PFS), and the secondary endpoint is safety.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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:
•1. Absolute number of neutrophils (ANN) ≥1500/mm3 (≥1.5 × 109/l);
•2. Platelet count ≥100,000/mm3 (IU: ≥100 × 109/l).
+5 more criteria

Exclusion Criteria

•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:
•1. Other malignancies, with the exception of malignancies treated more than 5 years ago without signs of return of the disease.
•2. Brain metastases or leptomeningeal metastases.
•3. Active infection (e.g. fever ≥38 °C), including active or unresolved pneumonia/pneumonitis.
•4. Uncontrolled diabetes mellitus.
•5. 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).
•6. Gastrointestinal bleeding within the last 2 weeks.
•7. Human immunodeficiency virus (HIV), chronic or acute hepatitis B or hepatitis C.
+6 more criteria

Locations (1)

Minsk City Clinical Oncology Center

Minsk, Belarus

Key Dates

Start Date

November 15, 2019

Primary Completion Date

December 30, 2024

Completion Date

December 30, 2024

Last Updated

August 7, 2023

Enrollment

ACTUAL participants

Conditions

Ovarian CancerPlatinum-resistant Ovarian Cancer

Interventions

Gemcitabine

DRUG

ELENAGEN

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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