Ovarian CancerPhase 2NCT05979298
Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
A Phase 2 study testing Gemcitabine and ELENAGEN in people with Ovarian Cancer and Platinum-resistant Ovarian Cancer, run by CureLab Oncology at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer, Platinum-resistant Ovarian Cancer
- What is being tested?
- Gemcitabine and ELENAGEN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelarus
- Study dates
- 15 Nov 2019to 30 Dec 2023
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Randomized Clinical Study of Plasmid Encoding p62/SQSTM1 (ELenagen) in in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
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.
Read the 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.
- Conditions
- Ovarian Cancer, Platinum-resistant Ovarian Cancer
- Being tested
- Gemcitabine, ELENAGEN
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Chemotherapeutics
ELENAGENBiological
DNA plasmid
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabin | Active comparator | Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks Receives: Drug: Gemcitabine |
| Gemcitabine+Elenagen | Experimental | GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly) Receives: Drug: Gemcitabine; Biological: ELENAGEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death. Progression is defined using RECIST v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 2 years since the start of treatment
Secondary outcomes (1)
Safety of Elenagen in Combination With Gemcitabine
Frequency of drug-related adverse events (AEs) and serious AEs (SAEs) according to NCI CTCAE version 5.0.
Measured: 1 year after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start15 Nov 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureLab Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979298
- Sponsor's protocol ID
- PROC0319
- Status last verified
- May 2026
- First submitted
- 19 Jul 2023
- Last updated
- 24 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not to be shared
Publications
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 Jul;36(7):104456. doi: 10.1016/j.ijgc.2025.104456. Epub 2026 Jan 7.
PubMed 41577503Krasny 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.
PubMed 38410116