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

July 27, 2023 updated by: CureLab Oncology

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus
        • Minsk City Clinical Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).
    3. Hemoglobin level ≥ 9.0 g/dL determined by analysis performed at least 2 weeks after the last hemotransfusion;
    4. The level of AST and ALT in blood serum not exceeding more than 3 times the upper limit of the norm.
    5. The level of serum bilirubin not exceeding more than 1.5 times the upper limit of normal.
    6. 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:

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.
    8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gemcitabin
Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks
Drug: Gemcitabine
Chemotherapeutics
Other Names:
  • Gemzar
Experimental: Gemcitabine+Elenagen
GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)
Drug: Gemcitabine
Chemotherapeutics
Other Names:
  • Gemzar
Biological: ELENAGEN
DNA plasmid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 2 years since the start of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Elenagen in combination with Gemcitabine
Time Frame: 1 year after the start of treatment
Frequency of drug-related adverse events (AEs) and serious AEs (SAEs) according to NCI CTCAE version 5.0.
1 year after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CureLab Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROC0319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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