To Evaluate the Efficacy and Safety of JPI-547 in Combination With Bevacizumab as Maintenance Therapy in Relapsed Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JPI-547, Bevacizumab.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Dose-finding and Randomized Active-controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of JPI-547 With Bevacizumab Maintenance Therapy in Relapsed Ovarian Cancer Patients Previously Treated With PARP Inhibitor Maintenance Therapy and Responding to Last Platinum Chemotherapy
Overview
This study aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients
Interventions
- Drug JPI-547
taking JPI-547 - Drug Bevacizumab
administration Bevacizumab
Primary outcome measures
- Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D) [Time frame: The dose-limiting toxicity evaluation window is 21 days]
- Part B: Progression free survival(PFS) [Time frame: 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine — Seoul
Identifiers
NCT: NCT07370818 · JPI-547-202