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

NCT05979298 | Unknown Phase 2

• 1 other identifier: PROC0319
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Platinum-resistant Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death

  2 years since the start of treatment

Secondary Outcomes (1)

• Safety of Elenagen in combination with Gemcitabine

  1 year after the start of treatment

Study Arms (2)

Gemcitabin

ACTIVE COMPARATOR

Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks

Drug: Gemcitabine

Gemcitabine+Elenagen

EXPERIMENTAL

GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)

Drug: Gemcitabine; Biological: ELENAGEN

Interventions

Gemcitabine DRUG

Chemotherapeutics

Also known as: Gemzar

Gemcitabin; Gemcitabine+Elenagen

ELENAGEN BIOLOGICAL

DNA plasmid

Gemcitabine+Elenagen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CureLab Oncology: lead

Study Sites (1)

Minsk City Clinical Oncology Center

Minsk, Belarus

Location

Related Publications (2)

• Krasny S, Baranau Y, Bakin E, Polyakov S, Streltsova O, Zharkova E, Filimonava A, Levin G, Gabai V, Shneider A. Elenagen, a p62/SQSTM1-encoding plasmid, improves overall survival in patients with platinum-resistant ovarian cancer: a phase II trial. Int J Gynecol Cancer. 2026 Jan 7:104456. doi: 10.1016/j.ijgc.2025.104456. Online ahead of print.

  PMID: 41577503 DERIVED

• Krasny S, Baranau Y, Polyakov S, Zharkova E, Streltsova O, Filimonava A, Siarheyeva V, Kazlouskaya S, Khorau A, Gabai V, Shneider A. Clinical efficacy of plasmid encoding p62/SQSTM1 (Elenagen) in combination with gemcitabine in patients with platinum-resistant ovarian cancer: a randomized controlled trial. Front Oncol. 2024 Feb 12;14:1343023. doi: 10.3389/fonc.2024.1343023. eCollection 2024.

  PMID: 38410116 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a prospective randomized multi-center study with two arms. Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks) was administered in both arms: In the Chemo arm (n = 20) GEM was the only treatment, and in the ELENAGEN arm (n = 20) GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly).

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 7, 2023
• Study Start: November 15, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)