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

Primary Purpose

Ovarian Cancer, Platinum-resistant Ovarian Cancer

Status
Active
Phase
Phase 2
Locations
Belarus
Study Type
Interventional
Intervention
Gemcitabine
ELENAGEN
Sponsored by
CureLab Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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: 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: 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.

Sites / Locations

  • Minsk City Clinical Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gemcitabin

Gemcitabine+Elenagen

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death

Secondary Outcome Measures

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.

Full Information

First Posted
July 19, 2023
Last Updated
July 27, 2023
Sponsor
CureLab Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT05979298
Brief Title
Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CureLab Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Platinum-resistant Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabin
Arm Type
Active Comparator
Arm Description
Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks
Arm Title
Gemcitabine+Elenagen
Arm Type
Experimental
Arm Description
GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Chemotherapeutics
Intervention Type
Biological
Intervention Name(s)
ELENAGEN
Intervention Description
DNA plasmid
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death
Time Frame
2 years since the start of treatment
Secondary Outcome Measure Information:
Title
Safety of Elenagen in combination with Gemcitabine
Description
Frequency of drug-related adverse events (AEs) and serious AEs (SAEs) according to NCI CTCAE version 5.0.
Time Frame
1 year after the start of treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Ovarian cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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: 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.
Facility Information:
Facility Name
Minsk City Clinical Oncology Center
City
Minsk
Country
Belarus

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not to be shared

Learn more about this trial

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

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