This is a phase-3, open-label, multicenter, two-arm treatment study to evaluate the efficacy and safety of weekly Paclitaxel Lipid Suspension compared with weekly conventional paclitaxel in participants with platinum-resistant/refractory recurrent high-grade serous epithelial ovarian cancer.
Paclitaxel Lipid Suspension or conventional paclitaxel will be administered intravenously at a dose level of 80 mg/m2 on Day 1, Day 8 and Day 15 of each 28 days cycle.
The primary objective is 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.
Participants in both arms will be dosed with the drug until disease progression as assessed by investigator and/or unacceptable toxicity.
The participant is willing to give written signed and dated informed consent to participate in the study.
Female ≥18 years of age fulfilling all other eligibility criteria.
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 (<50% of the primary tumor confirmed to be high-grade serous) epithelial/non-epithelial tumors (including malignant mixed Müllerian 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.
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.
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.
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.
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.
Participants who are using known strong CYP3A4 inducers, CYP3A4 inhibitors, CYP2C8 strong inhibitors, and strong inducers.
Parallel
Paclitaxel Lipid Suspension
DrugThe formulation consists of uniformly sized (\< 100 nm) particles of Paclitaxel suspended in a lipid-based formulation. The advantage of such a Lipid-Based formulation of Paclitaxel is an improvement of the safety profile by eliminating excipients, Cremophor and ethanol which are present in conventional Paclitaxel formulations (Taxol®).
Conventional paclitaxel or Taxol
DrugConventional formulation with detergent Cremophor and alcohol
Confirmed Objective Response Rate
The proportion of participants whose Best Overall Response is a confirmed CR or PR as determined by blinded independent central review (BICR) based on RECIST v1.1
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