Paclitaxel Lipid Suspension for Patients with Platinum-Resistant /Refractory Ovarian Cancer

Exclusion Criteria

• •15. Participants must have progressed radiologically on or after their most recent line of systemic therapy. Biochemical progression will not be considered progression for this study.
• •1. Have previously received paclitaxel at any time in the platinum-resistant setting. This does not apply to the participants who have received paclitaxel either in a neo/adjuvant setting in the first line or platinum-sensitive relapse.
• •2. Participants who are candidates for debulking surgery, or in whom chemotherapy is planned to shrink the otherwise inoperable tumor and make it operable even if the intent is palliative.
• •3. Participants who are planned to receive concurrent PARP inhibitors based on BRCA positivity and HRD status in line with approved indications of respective PARP inhibitors.
• •4. Participants who are using known strong CYP3A4 inducers, CYP3A4 inhibitors, CYP2C8 strong inhibitors, and strong inducers.
• •5. Participants who are planned for concurrent bevacizumab along with IMP for their disease management during the study. Participants who have received bevacizumab in the past for the management of ovarian cancer are eligible.
• •Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently).
• •6. Participants with clinically significant current or recent (within the past 6 months before randomization) cardiac conditions as defined below:
• •* Unstable angina
• •* Myocardial infarction
• •* Severe uncontrolled ventricular arrhythmias
• •* Clinically significant pericardial disease
• •* Electrocardiographic evidence of acute ischemia
• •* Participants with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable
• •* History of cardiac disease that met the NYHA Classification class 2 or greater
• •* Cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
• •7. Uncontrolled diabetes (defined as HbA1c ≥8% as per ADA) or has an active infection requiring systemic therapy.
• •8. History of drug or alcohol abuse according to medical history assessment by the investigator within 1 year before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at Screening.
• •9. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks before the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 28 days before trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
• •10. The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days before the first dose of an investigational medicinal product for the current study.
• •11. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 as defined by NCI CTCAE v5.0 criteria.
• •12. History of clinically significant liver or renal insufficiency; vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that, in the investigator's judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
• •13. Participants who are unwilling or unable to follow protocol requirements.
• •14. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.
• •15. Prior known hypersensitivity reactions to and/or any of their excipients.