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To Evaluate the Efficacy and Safety of JPI-547 in Combination With Bevacizumab as Maintenance Therapy in Relapsed Ovarian Cancer

ConditionOvarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age19+
SponsorOnconic Therapeutics Inc.

About this trial

This study aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JPI-547

    Drug

    taking JPI-547

  • Bevacizumab

    Drug

    administration Bevacizumab

Treatment groups

81 Participants
are divided into 2 treatment groups
Group A: JPI-547+BevacizumabExperimental treatment 2 interventions
Group B: BevacizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D)

Time frame
The dose-limiting toxicity evaluation window is 21 days
2

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Onconic Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: