Safety and efficacy study to evaluate AsiDNA in addition with Niraparib for treatment of relapsed platinum sensitive ovarian cancer already treated with Niraparib since at least 6 months
- Conditions
- Relapsed platinum sensitive ovarian cancerMedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000825-18-FR
- Lead Sponsor
- Gustave Roussy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 26
1. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
2. Female aged = 18 years (no upper limit of age) at the time of consent signature.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of at least 3 months.
5. Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer regardless BRCA status.
6. Availability of BRCA status;
7. Patient has received at least 2 previous courses of platinum-containing therapy and has a disease that was considered platinum sensitive that means in response (complete or partial) to the last platinum course leading to the administration of Niraparib.
8. The patient has received Niraparib in maintenance for at least 6 months and who has only an increase of CA125 at least twice the upper limit of normal within 2 weeks prior to starting treatment without any progression according to RECIST criteria
9. Patient should be treated within 2 weeks after CT scan without any progression according to RECIST criteria
10. Patient with adequate biological parameters at baseline defined as:
• absolute neutrophil count (ANC) = 1.5 x 10e9/L,
• hemoglobin (Hb) level = 9g/dL,
• platelet count = 100 x 10e9/L,
• total bilirubin level = 1.5 Upper Limit Normal (ULN),
• aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 x ULN,
• calculated glomerular filtration rate (GFR) = 60 mL/min/1.73m2 (per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula),
• INR = 1.2 (except if patient treated with anti-vitamine K); anticoagulation with anti-vitamin K and Low Molecular Weight Heparin [LMWH] is allowed.
11. Patient of childbearing potential must agree to use adequate contraception prior to study entry, during the study and for 3 months after the study participation.
12. Patient of childbearing potential must have a serum negative pregnancy test within 4 days prior to first administration. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
13. Patient must be affiliated to a social security system or an equivalent system.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
2. Patient treated concomitantly with bevacizumab
3. Patient previously treated with PARPi as first line maintenance
4. Other Malignancy within the last 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix, and in situ breast cancer
5. Patient with central nervous system (CNS) metastases;
6. Other tumor location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery or radiation therapy, such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture).
7. Patient with uncontrolled disease-related metabolic disorder (e.g., hypercalcemia, SIADH) or uncontrolled diabetes.
8. Quantitative total urine protein > 1.0 g/24 hour) at baseline
9. Patient with uncontrolled congestive heart failure defined as New York Heart Association (NYHA) class III or IV, uncontrolled hypertension, unstable heart disease (e.g., coronary artery disease with unstable angina or myocardial infarction within 6 months before study treatment administration).
10. Patient with significant ECG abnormalities defined as any cardiac dysrhythmia (> grade 2) (i.e., significant ventricular arrhythmia as persistent ventricular tachycardia and/or ventricular fibrillation; severe conduction disorders as atrio-ventricular block 2 and 3, sino-atrial block) or baseline QT/QTc interval >480 milliseconds (ms).
11. Patient with significant chronic liver disease (e.g., significant fibrosis, known cirrhosis) or active HBV or HCV infection; if AgHbs positive, an effective antiviral treatment to prevent hepatitis B reactivation is recommended.
12. Patient with HIV infection or an active infection requiring specific anti-infective therapy are not eligible until all signs of infection have resolved, and this within 2 weeks prior to the first study treatment administration.
13. Patient whose medical, psychological including alcohol or drug abuse, or surgical conditions are unstable and may affect the study completion and/or compliance and/or the ability to give informed consent.
14. Participation in another clinical trial with any investigational drug within 28 days prior to first study drug administration.
15. Vulnerable adult patients benefiting from a specific legal protection status.
16. Patient who has received mouse antibodies (unless the assay used has been shown not to be influenced by HAMA4,5) or if there has been medical and/or surgical interference with their peritoneum or pleura during previous 28 days.
17. Patient pregnant or breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Part A: Overall Safety<br>Part B: Preliminary efficacy on CA-125<br>;Timepoint(s) of evaluation of this end point: Part A: First cycle of treatment (from D1 to D21)<br>Part B: After 2 cycles of treatment (from D1 to D42);Main Objective: Part A: to assess safety of iv infusions of AsiDNA in addition to Niraparib during the first cycle<br>Part B: to assess preliminary efficacy on CA-125 of AsiDNA in addition to Niraparib<br>;Secondary Objective: Part A and B<br>-Overall safety of iv infusions of AsiDNA in addition to Niraparib<br>-CA 125 (Part A)<br>-Progression-Free Survival<br>-Overall Survival<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Part A and B:<br>- Overall Safety of iv infusions of AsiDNATM in addition to Niraparib<br>- CA 125 (for Part A)<br>- Progression-Free Survival<br>- Overall Survival;Timepoint(s) of evaluation of this end point: Throughout the trial