Health Condition 1: N00-N99- Diseases of the genitourinary system
Conditions
Interventions
Intervention1: Paclitaxel Lipid Suspension for Injection (1 mg/mL)-T: Each vial contains lyophilized Paclitaxel lipid
powder, equivalent to 60 mg or 100 mg of anhydrous Paclitaxel
Dose: 80 mg/m2 weekl
Sponsors
Jina Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1) The participant is willing to give written signed and dated informed consent to participate in the study. 2) Female greater than or equal to 18 years of age fulfilling all other eligibility criteria. 3) Participants must have histopathologically cytologically confirmed diagnosis of high-grade serous epithelial carcinoma of the ovary, fallopian tube cancer or primary peritoneal carcinoma. Non-epithelial or mixed (less than 50 percentge of the primary tumor confirmed to be high-grade serous) epithelial non-epithelial tumors (including malignant mixed M llerian tumors), ovarian tumors with low malignant potential (borderline tumors), endometrioid, clear cell, mucinous or low-grade serous carcinomas or not otherwise specified (NOS) ovarian tumors are excluded. Refer to Appendix 8 for criteria defining high-grade serous ovarian carcinoma. 4) Platinum resistant or refractory disease as per standard clinical and Gynecologic Oncology Group definition. Platinum-resistant refractory disease is defined as disease progression within 6 months (182 days) following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory), respectively for whom single-agent paclitaxel is considered an acceptable therapeutic option by the investigator. Note: Progression due to rising CA125 only is not considered a platinum-resistant disease. Disease progression may be either radiographic progression or documented clinical progression. The residual disease is not considered progression. Progression on a nonplatinum- containing regimen is eligible if the participant is considered platinum-resistant to the last platinum-containing regimen. 5) Participants must have received at least one-prior platinum-based chemotherapy regimen, including cisplatin, carboplatin or other organoplatinum compounds, for treatment of primary or recurrent ovarian, fallopian tube or primary peritoneal cancer. 6) Have at least one measurable lesion as per the RECIST criteria (version 1.1). 7) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1. 8) Left Ventricular Ejection fraction (LVEF) greater than or equal to 50 percentage as per Echocardiography (ECHO). 9) Participant has recovered from adverse events (baseline or less than or equal to CTCAE Grade 1) due to prior anti-cancer therapy(ies) (including surgery, radiotherapy, chemotherapy, targeted therapy, hormonal therapy) unless AE(s) is either clinically nonsignificant or stable on supportive therapy or do not constitute a safety risk to the participant as determined by the investigator. 10) Participants with life expectancy of at least 6 months in the Investigators opinion. 11) A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 5: Contraception and Barrier Guidance. Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in section Appendix 5: Contraception and Barrier Guidance during the intervention period and for at least 6 months after the last dose of IMP. The investigator should
Exclusion criteria
Exclusion criteria: 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. Refer Appendix 2 for detailed list of Inhibitors and 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 greater than or equal to 8 percentage 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 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 greater than or equal to 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, psyc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the non-inferiority of Paclitaxel Lipid Suspension in comparison with Conventional Paclitaxel for Injection in participants with platinum-resistant/refractory recurrent advanced high-grade serous epithelial ovarian cancer including fallopian tube and or primary peritoneal cancer.Timepoint: Pre-dose (prior to the start of infusion), 0.167, 0.333, 0.500, 0.750, 1.000 (i.e. immediately after the actual end of infusion), 1.333, 1.667, 2.000, 3.000, 4.000, 5.000, 6.000, 8.000, 10.000, 16.000, 24.000 and 36.000 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate population pharmacokinetic, safety and tolerability of IMP in participants with platinum-resistant refractory recurrent advanced high-grade serous epithelial ovarian cancer including fallopian tube and or primary peritoneal cancerTimepoint: Pre-dose (prior to the start of infusion), 0.167, 0.333, 0.500, 0.750, 1.000 (i.e. immediately after the actual end of infusion), 1.333, 1.667, 2.000, 3.000, 4.000, 5.000, 6.000, 8.000, 10.000, 16.000, 24.000 and 36.000 | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed