Paclitaxel Lipid Suspension for Patients with Platinum-Resistant /Refractory Ovarian Cancer (NCT06867562) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Paclitaxel Lipid Suspension for Patients with Platinum-Resistant /Refractory Ovarian Cancer
166 participantsStarted 2025-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. 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.
. Have at least one measurable lesion as per the RECIST criteria (version 1.1).
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
✓. Left Ventricular Ejection fraction (LVEF) ≥50% as per Echocardiography (ECHO).
Exclusion criteria
✕. 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.
✕. 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.
✕. Participants with clinically significant current or recent (within the past 6 months before randomization) cardiac conditions as defined below:
✕. Uncontrolled diabetes (defined as HbA1c ≥8% as per ADA) or has an active infection requiring systemic therapy.
✕. 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.