Ovarian Cancer
Conditions
Brief summary
This study aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients
Interventions
DRUGJPI-547
taking JPI-547
DRUGBevacizumab
administration Bevacizumab
Sponsors
Onconic Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer \[High-grade serous carcinoma (HGSC), Grade 2/3 endometrioid carcinoma\] * Patients whose BRCA 1/2 gene mutation status and/or Homologous Recombination Deficiency (HRD) status. * Patients who received platinum-based chemotherapy followed by PARP inhibitor maintenance therapy, * Patients who had received chemotherapy before participating in the clinical trial and responded to platinum-based chemotherapy. * Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Individuals with confirmed adequate hematological, renal, and hepatic function (laboratory tests may be repeated once during the screening period)
Exclusion criteria
* Patients with a history of severe drug hypersensitivity or hypersensitivity to the investigational drug, its components, or drugs within the same class. * Individuals with dysphagia * Patients with a confirmed specific medical history or a past surgical history. * Patients with specific comorbidities or medical abnormalities. * Pregnant women, lactating women, or women of childbearing potential who do not agree to use appropriate contraception during the clinical trial period and for 24 weeks after administration of the investigational medicinal product. * Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline * Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D) | The dose-limiting toxicity evaluation window is 21 days |
| Part B: Progression free survival(PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months. |
Countries
South Korea
Contacts
CONTACTOnconic Therapeutics Inc.
Outcome results
None listed