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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05979298
• Other study ID #: PROC0319
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 15, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: CureLab Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Platinum-resistant Ovarian Cancer

Intervention

Drug:
• Gemcitabine
Chemotherapeutics

Biological:
• ELENAGEN
DNA plasmid

Locations

Country	Name	City	State
Belarus	Minsk City Clinical Oncology Center	Minsk

Sponsors (1)

Lead Sponsor	Collaborator
CureLab Oncology

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year after the start of treatment