A Study to Evaluate the Efficacy and Safety of JPI-547 in Platinum-resistant, Advanced/Relapsed Ovarian Cancer Subjects Previously Treated With a PARP Inhibitor
- Conditions
- Ovarian Cancer
- Registration Number
- NCT05475184
- Lead Sponsor
- Onconic Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Patients with advanced/metastatic high-grade serous epithelial ovarian, fallopian<br> tube or primary peritoneal cancer*:<br><br> 1. who has undergone =2 previous chemotherapy regimen;<br><br> 2. with confirmed platinum resistance**;<br><br> 3. =3 month PARP inhibitor treatment history;<br><br> 4. confirmed BRCA1/2 mutation *** or HRD ***<br><br> - Subjects with at least one measurable lesion in accordance with RECIST v1.1<br><br> - Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1<br><br> - Subjects with life expectancy =12 weeks<br><br> - Patients with adequate hematologic, kidney, and liver functions confirmed using the<br> following criteria (retesting of laboratory tests is allowed once during screening)<br><br> - Subjects who voluntarily decided to participate in this study after being fully<br> informed and gave informed consent<br><br>Exclusion Criteria:<br><br> - Subjects who meet any of the following conditions cannot participate in this study:<br><br> 1. Subjects with a history of severe drug hypersensitivity or the hypersensitivity<br> to IP and its ingredients or similar drugs<br><br> 2. Subjects with dysphagia<br><br> 3. Subjects confirmed with the following medical or surgical/procedural history:<br><br> - Primary malignant tumor other than ovarian cancer diagnosed or treated within 24<br> months prior to baseline (individuals with successfully treated cutaneous<br> basal/squamous cell carcinoma are eligible for enrollment)<br><br> - Major surgery requiring general anesthesia or respiratory support within 4 weeks<br> prior to baseline (2 weeks for video-assisted thoracoscopic surgery [VATS] or<br> open-and-closed [ONC] surgery)<br><br> - Severe cardiovascular disease (e.g., myocardial infarction and unstable angina) that<br> occurred within 24 weeks prior to baseline<br><br> - New York Heart Association Class 3 or 4 heart failure within 24 weeks prior to<br> baseline<br><br> - Severe cerebrovascular disease observed within 24 weeks prior to baseline<br><br> - Pulmonary thrombosis or deep vein thrombosis within 24 weeks prior to baseline, or<br> bronchial asthma, obstructive pulmonary disease, or other serious, life-threatening<br> lung disease (e.g., acute respiratory distress syndrome and lung failure) considered<br> ineligible for study participation<br><br> - Infections requiring treatment, such as systemic antibiotics and antivirals, within<br> 2 weeks prior to baseline, or other uncontrolled =Grade 3 active infectious diseases<br><br> - Symptomatic interstitial lung disease<br><br> - Subjects who showed poor recovery from hematologic toxicity in the past chemotherapy<br> (e.g., =grade 3 toxicity for =4 weeks)<br><br> - Bone marrow or stem cell transplantation with high-dose chemotherapy<br><br> - Total gastrectomy or total duodenectomy<br><br> - Individuals with a history of myelodysplastic syndrome (MDS) or pretreatment<br> cytogenetic test results indicating a risk of MDS/acute myeloid leukemia (AML) 4)<br> Subjects with the following concurrent conditions:<br><br> - Subjects with clinically significant symptoms or uncontrolled central nervous system<br> or brain metastases (except when systemic corticosteroid administration was stopped<br> at least 4 weeks prior to baseline and was stable for =4 weeks)<br><br> - Subjects who have confirmed clinically significant conditions in the<br> electrocardiogram (ECG) according to the investigator's judgment<br><br> - Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood<br> pressure >90 mmHg)<br><br> - Bleeding diatheses<br><br> - Active hepatitis B or C virus infection (patients with hepatitis may participate if<br> HBV DNA and HCV RNA are below the lower limit of detection established by the study<br> site)<br><br> - Known human immunodeficiency virus infection (HIV) positive<br><br> - Subjects with neurological and psychiatric disorders severe enough to affect the<br> study results according to the investigator's judgment 5) Subjects who have the<br> following drug treatment history:<br><br> - Subjects who have received chemotherapy†, immunotherapy (including biologics),<br> hormone therapy, or therapeutic/palliative radiotherapy‡ within 4 weeks prior to<br> baseline<br><br> - Subjects who require continuous (=4 weeks) treatment of systemic corticosteroids<br> equivalent to prednisone >10 mg/day<br><br> - Subjects who were treated with antithrombotic drugs, including antiplatelet agents<br> and anticoagulants, within 2 weeks from baseline or are expected to be treated with<br> them during the study period (however, low molecular weight heparin [LMWH])<br> treatment is allowed)<br><br> - Subjects who require continuous administration of non-steroidal anti-inflammatory<br> drugs (NSAIDs), which have high risk of bleeding 6) Pregnant or lactating women, or<br> women of childbearing potential who do not intend to abstain or use appropriate<br> contraceptive methods during the study period and up to 3 months after IP<br> administration *Appropriate contraception: 7) Subjects who have taken or undergone<br> another IP or investigation device within 4 weeks prior to baseline 8) subjects who<br> are judged by the investigator as ineligible for study participation
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate(ORR)
- Secondary Outcome Measures
Name Time Method Anti-tumor activity