CTRI/2025/10/096192尚未招募3 期
A Phase-3, Randomized, Parallel Group, Open-label, Multicenter, Two-Arm Treatment Study to Evaluate the Efficacy and Safety of Weekly Paclitaxel Lipid Suspension Compared with Weekly Conventional Paclitaxel in the Patients with Platinum-Resistant/Refractory Recurrent High-grade Serous Epithelial Ovarian Cancer Including Fallopian Tube and/or Primary Peritoneal Cancer
Jina Pharmaceuticals Inc9 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2025年10月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 166
- 试验地点
- 9
- 主要终点
- To establish the non-inferiority of Paclitaxel Lipid Suspension in comparison with Conventional
研究概览
简要总结
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 and 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 cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •The participant is willing to give written signed and dated informed consent to participate in the study.
- •Female greater than or equal to 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 (less than 50 percentge 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.
- •Refer to Appendix 8 for criteria defining high-grade serous ovarian carcinoma.
- •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.
- •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 less than or equal to
- •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.
- •Participants with life expectancy of at least 6 months in the Investigators opinion.
- •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 evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of IMP.
- •A WOCBP agrees not to donate eggs (ova, oocytes) or freeze them for future use for reproduction during the recommended period of contraception.
- •A WOCBP agrees to seek advice about the donation and cryopreservation of germ cells.
- •A WOCBP must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test within 24 hours before the first dose of IMP.
- •If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
- •In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
- •Participants with adequate bone marrow, renal and hepatic function as defined below: a) ANC greater than or equal to 1500 per mm3 without granulocyte colony-stimulating factor support within 1 week before the screening assessment.
- •b) Platelet counts greater than or equal to 100,000 per mm3 without any platelet transfusion per platelet concentrate within 1 week before the screening assessment.
- •c) Hemoglobin greater than or equal to 9 gm per dL.
- •Criteria must be met without packed red blood cells (pRBC) or whole blood transfusion within 1 week before the screening assessment.
- •d) Creatinine clearance greater than or equal to 30 mL per min as calculated using the Cockcroft-Gault equation e) Total bilirubin less than or equal to ULN f) ALT per AST less than or equal to 1.5 times ULN (less than or equal to 5.0 into ULN if liver metastases are present) g) Alkaline phosphatase less than or equal to 2.5 times ULN (less than or equal to 5.0 into ULN if liver metastases are present) 13) Has had prior PARP inhibitors for participants with documented breast cancer gene (BRCA) mutation (germline and or somatic) or HRD status, unless the participant is not eligible for treatment with a PARP inhibitor due to precautions intolerance, or if the treatment is not approved locally or not available due to any reasons.
- •Note: BRCA and or HRD status will be based on history of documented testing and participants will not be screened for BRCA and or HRD testing for the current study.
- •Participant without known BRCA HRD status will be considered as negative benign.
- •Has had prior treatment with mirvetuximab soravtansine for participants with documented high folate receptor alpha expression, unless the participant is not eligible for treatment with mirvetuximab soravtansine due to precautions intolerance, or if the treatment is not approved or available locally.
- •Note: Folate receptor alpha expression will be based on history of documented testing and participants will not be screened for folate receptor alpha expression testing for the current study.
- •Participant without known expression status will be considered as negative for Folate receptor alpha expression.
- •Biochemical progression will not be considered progression for this study.
排除标准
- •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.
- •Refer Appendix 2 for detailed list of Inhibitors and 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.
- •Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently).
- •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.
- •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.
- •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.
- •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.
- •Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade 2 as defined by NCI CTCAE v5.0 criteria.
- •History of clinically significant liver or renal insufficiency; vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that, in the investigators judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •Participants who are unwilling or unable to follow protocol requirements.
- •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.
结局指标
主要结局
To establish the non-inferiority of Paclitaxel Lipid Suspension in comparison with Conventional
时间窗: 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
Paclitaxel for Injection in participants with platinum-resistant/refractory recurrent advanced
时间窗: 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
high-grade serous epithelial ovarian cancer including fallopian tube and or primary peritoneal
时间窗: 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
cancer.
时间窗: 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
次要结局
- 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 cancer(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)
研究者
Dr Naman Shah
Lambda Therapeutic Research Ltd
研究点 (9)
Loading locations...
相似试验
招募中
2 期
Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian CancerOvarian CancerNCT07261683Obstetrics & Gynecology Hospital of Fudan University20
招募中
不适用
A Single Arm Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) PasseoTM-18 LuxTM Drug-coated Balloon in the Treatment of Subjects With Infrainguinal Stenotic, Restenotic or Occlusive LesionsPeripheral Arterial DiseaseNCT07385573KANDO Research200
尚未招募
3 期
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast CancerNCT07406542CSPC Megalith Biopharmaceutical Co.,Ltd.400
招募中
3 期
A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum.2024-516530-36-00Cancer Trials Ireland20
尚未招募
3 期
A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell CarcinomaNCT07446335The First Affiliated Hospital of Zhengzhou University578