[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jina Pharmaceuticals Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,66,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100337253","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-nanosomal-docetaxel-lipid-suspension-in-triple-negative-breast-cancer-patients-100337253",false,"NCT03671044","A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients","A Global, Multicenter, Three Arms, Open-label Randomized Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere® (Docetaxel Injection Concentrate) in Triple-negative Breast Cancer Patients With Locally Advanced or Metastatic Breast Cancer After Failure to Prior Chemotherapy","Inclusion Criteria:\n\n1. The patient willing to give written signed and dated informed consent to participate in the study.\n2. Patient must have histopathologically or cytologically confirmed triple negative breast cancer.\n3. Patients may have received one prior chemotherapy regimen for adjuvant therapy and\u002For one chemotherapy treatment\u002Fregimen for firstline metastatic therapy\n4. Patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.\n5. Have at least one measurable lesion as per the RECIST criteria (version 1.1).\n6. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to two\n7. Left Ventricular Ejection fraction (LVEF) greater than or equal to 50 percentage as per Echocardiography (ECHO).\n8. Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator.\n9. Previous chemotherapy or radiotherapy should be completed 4 weeks prior to start of IMP administration.\n10. Patients with life expectancy of at least 6 months.\n11. Serum pregnancy test at screening and urine pregnancy test on Day 1 (before randomization) must be negative.\n12. Sexually active women, unless surgically sterile or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \\[any hormonal method in conjunction with a secondary method\\], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \\[at least 6 months prior to Study drug administration\\] sexual partner) for at least four weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.\n13. Patient with adequate bone marrow, renal and hepatic function.\n\nExclusion Criteria:\n\n1. Patient who has a history of hypersensitivity reactions to Docetaxel or any other component of formulation or to any drugs formulated with polysorbate 80.\n2. Patients with a history of HER2 positive over expression and hormone receptor positive (ER or PR)\n3. Patient who is already exposed to Docetaxel injection in metastatic setting.\n4. Any of the cardiac conditions like Unstable angina, Myocardial infarction within the past six months, Severe uncontrolled ventricular arrhythmias, Clinically significant pericardial disease, Electrocardiographic evidence of acute ischemia, Patient with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable for the past six months, History of cardiac disease that met the NYHA Classification class 2 or greater\n5. Uncontrolled diabetes or infection.\n6. Known history of drug addiction within last one year.\n7. Patients with known CNS lesions (brain metastasis or carcinomatous meningitis) except for asymptomatic brain metastases.\n8. The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dose of investigational medicinal Product for the current study.\n9. Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade two as defined by NCI CTCAE 4.03 criteria.\n10. Known case of HIV infection.\n11. Any other condition that, in the investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.\n12. Patients who are unwilling or unable to follow protocol requirements","FEMALE","18 Years","65 Years",{"count":20,"type":21},657,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The Nanosomal Docetaxel Lipid Suspension (NDLS) consists of uniformly sized micro particles of docetaxel suspended in a lipid based formulation. The advantage of such a Lipid Based formulation of Docetaxel is an improvement of the safety profile by eliminating excipients, polysorbate 80 and ethanol which are present in conventional Docetaxel formulations (Taxotere®). This randomized, open-label study is designed to assess the efficacy and safety of Nanosomal Docetaxel Lipid Suspension at the dose of 75 mg\u002Fm2 and at the dose of 100 mg\u002Fm2 compared to Taxotere® at the dose of 100 mg\u002Fm2 in triple-negative breast cancer patients with Locally Advanced or Metastatic Breast Cancer. Patients will continue the treatment in the absence of disease progression and unacceptable toxicity. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. 657 patients (219 patients per arm) will be randomized in the study. The trial will be conducted as per the ICH GCP Guidelines E6 (R1), Schedule Y (Amended Version 2013), Declaration of Helsinki (Fortaleza, Brazil, October 2013), ICMR Guidelines for Biomedical Research on Human subjects and in accordance with other applicable guidelines.",[27],"Triple Negative Breast Cancer",[27,29],"Docetaxel","RECRUITING","2025-03-19",{"date":33,"type":34},"2025-03-21","ACTUAL",{"date":36,"type":34},"2018-07-10",{"date":38,"type":21},"2025-12-31",{"name":40,"class":41},"Jina Pharmaceuticals Inc.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100584552","phase-2-a-study-to-investigate-efficacy-and-safety-of-different-dose-regimen-of-oral-cabazitaxel-tablet-in-adult-participants-with-prostate-cancer-100584552","NCT06890832","A Study to Investigate Efficacy and Safety of Different Dose Regimen of Oral Cabazitaxel Tablet in Adult Participants with Prostate Cancer","A Phase-2, Open-label, Randomized, Parallel-Group, Three-Arm Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel-containing Treatment Regimen","Inclusion Criteria:\n\n1. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study.\n2. Male participant ≥18 years of age at the time of signing the informed consent.\n3. Participant must have histological pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate.\n4. Evidence of metastatic disease.\n5. Participant must be previously treated with a docetaxel-containing regimen (at least 3 cycles) for the treatment of prostate cancer (including locally confined inoperable disease that cannot be treated with definitive intent) and\u002For CRPC. Docetaxel administration in combination with androgen deprivation therapy (ADT) with or without next-generation AR-targeted therapy (abiraterone acetate, enzalutamide, or and next generation targeted agents Darolutamide, apalutamide) in metastatic hormone-sensitive disease is considered a prior docetaxel exposure.\n6. Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration.\n7. Participant must be taking ADT with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤1.73 nmol\u002FL (50 ng\u002FdL) at the screening visit.\n8. Participant must be eligible for treatment with cabazitaxel per the locally approved prescribing information.\n9. ECOG PS grade of 0-2. ECOG PS 2 must be related to prostate cancer, not to other comorbidities.\n10. Estimated life expectancy of ≥6 months as assessed by the investigator.\n11. Participant has recovered from AEs (baseline or ≤ CTCAE Grade 1) due to prior anticancer 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.\n12. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last dose of study intervention:\n\n    * Must agree not to plan to father a child or donate sperm for the purpose of reproduction. PLUS, either of the following:\n    * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR\n    * Must agree to use contraception \u002Fbarrier\n13. Participant with adequate hematologic, liver and renal function.\n14. Willing and able to adhere to the lifestyle restrictions specified in this protocol.\n\nExclusion Criteria:\n\n1. Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components\u002F excipients thereof (refer to the IB), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.\n2. Contraindications to the use of prednisone or medical ADT per locally approved prescribing information.\n3. Previous treatment with cabazitaxel in any setting.\n4. Had major surgical procedure or significant traumatic injury requiring general anaesthesia within 4 weeks or will not have fully recovered from surgical procedure prior to first dose of the study intervention; or has surgical procedure planned during the time the participant is expected to participate in the study.\n5. Prior isotope therapy, whole pelvic radiotherapy or radiotherapy to \\>30% of bone marrow within 3 months prior to Baseline.\n6. Symptomatic peripheral neuropathy Grade ≥2 (National Cancer Institute Common Terminology Criteria \\[NCI CTCAE\\] v.5.0).\n7. Presence of hepatitis B surface antigen (HbsAg) at screening or within 3 months prior to first dose of investigational intervention.\n8. Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention.\n9. Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.\n10. History of malignancy (except for prostate cancer) within the past 5 years except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy.\n11. • Current or chronic history of liver disease. This includes \\[but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator.\n\n    • Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n12. Participant with clinically significant current or recent (within the past 3 months before randomization \\[unless otherwise specified below\\]) cardiac conditions.\n13. Known active CNS disease, except for treated stable asymptomatic CNS metastases.\n14. Known Leptomeningeal disease.\n15. Unmanageable concurrent bladder outflow obstruction or urinary incontinence.\n16. Has an active infection requiring systemic therapy.\n17. Spinal cord compression not definitively treated with surgical procedure and\u002For radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥4 weeks prior to Baseline.\n18. Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer.\n19. Unable to swallow solid, oral dosage forms whole with the aid of water (participants cannot chew, divide, dissolve, or crush the investigational intervention) or and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication.\n20. Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.","MALE",{"count":51,"type":21},75,[53],"PHASE2","A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6.\n\nThe study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year.\n\nKey efficacy assessments include CT scans\u002FMRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments.\n\nPharmacokinetic parameters will also be evaluated.",[56],"Metastatic Castration-resistant Prostate Cancer, MCRPC","NOT_YET_RECRUITING","2025-03-17",{"date":60,"type":34},"2025-03-24",{"date":62,"type":21},"2025-05",{"date":64,"type":21},"2027-06",{"name":40,"class":41},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":73,"minAge":17,"maxAge":18,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100582725","phase-2-tacrolimus-lipid-suspension-for-enema-in-adult-subjects-with-mild-to-moderately-active-left-sideddistal-ulcerative-colitis-who-had-an-inadequate-response-to-the-treatment-100582725","NCT06867042","Tacrolimus Lipid Suspension for Enema in Adult Subjects with Mild to Moderately Active Left-sided\u002FDistal Ulcerative Colitis Who Had an Inadequate Response to the Treatment","A Double-blind, Randomized, Multicenter, Parallel, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Tacrolimus Lipid Suspension for Enema in Adult Subjects with Mild to Moderately Active Left-sided\u002FDistal Ulcerative Colitis Who Had an Inadequate Response to the Treatment","Inclusion Criteria:\n\n1. Male and female patients ≥ 18 years and ≤ 65 years of age.\n2. Patients have a documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria involving the whole or part of the left side of the colon \\[approximately 60 cm up from the anus (anal verge) to splenic flexure of colon\\], with mild to moderate active disease.\n3. Patients with a score of at least 4 on the modified Mayo Score (mMS), including an endoscopy subscore of at least 2 and a rectal bleeding subscore of at least 1.\n4. Patients who have inadequate response, loss of response, or intolerance of at least 1 of aminosalicylates (5-ASAs) (mesalamine, sulfasalazine, olsalazine, basalazide), corticosteroids, azothiopurine, mercaptopurine and methotrexate and need an alternative therapy as per the discretion of the Investigator.\n5. Patients who have failed to achieve total resolution of all symptoms to topical and\u002For oral standard treatment regimen of aminosalicylates (mesalamine, sulfasalazine, olsalazine, basalazide) or corticosteroids, azathioprine, mercaptopurine and methotrexate over minimum 4-week duration and need an alternative therapy as per the discretion of the Investigator. Determination of the outcomes of prior therapies should be made after the completion of at least one induction regimen and one maintenance regimen, as appropriate, for the prior therapy.\n6. The patients who do not show evidence of benefits with the use of Biologics (e.g. Anti-integrins, Anti-TNFalpha and Anti-interleukins) for ulcerative colitis can be enrolled in the study. However, after a washout duration of 5 half-lives from any prior biologic treatments prior to enrollment is required. A shorter washout duration (e.g., 3 half-lives) is acceptable if undetectable drug levels of the biologic can be demonstrated.\n\n   Note: Absence of benefit (inadequate response) is defined as signs and symptoms of persistently active disease despite an adequate trial of induction treatment with an anti-TNF-α agent (per country's approved label); OR recurrence of symptoms during maintenance dosing following prior clinical benefit;\n7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   1. Is not a woman of childbearing potential (WOCBP) OR\n   2. Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency when used consistently and correctly during the intervention period and for at least 6 weeks after the last dose of study intervention. 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 study intervention.\n   3. A WOCBP must have a negative pregnancy test (serum) at screening and a negative pregnancy test (urine) before the first dose of study intervention.\n\n   Note: The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n8. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 weeks after the last dose of study intervention:\n\n   1. Must agree not to donate sperm for the purpose of reproduction\n\n      PLUS EITHER OF B or C:\n   2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR\n   3. Must agree to use contraception \u002Fbarrier as detailed below\n\n   i. A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person.\n\n   ii. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant\n9. Patient can understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.\n10. Patients with adequate vitals, hematologic, liver and renal function at screening visit\n11. If drugs such as aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide) or corticosteroids, azothiopurine, mercaptopurine and methotrexate recently discontinued, they must have been stopped for at least 2 weeks (for aminosalicylates, and corticosteroids)\u002F8-week duration (for azathioprine, mercaptopurine, and methotrexate) prior to the endoscopy used for baseline modified Mayo Score (mMS).\n12. For 30 patients undergoing intensive PK substudy:\n\n    * Agree to undergo PK sampling procedure.\n    * Participant having adequate venous access.\n\nExclusion Criteria:\n\n1. Documented history of proximal or universal ulcerative colitis (pan colitis).\n2. Patients who receive mMS score of 8 or greater (severe disease)\n3. Patients with known allergy to study drugs or have a history of serious AEs related to their use.\n4. Patients who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.\n5. Prior documented history of high-grade dysplasia on biopsy from endoscopic examinations.\n6. Presence of enteric pathogens or Clostridium difficile toxins in stool samples.\n7. History of recurrent Clostridium difficile infection.\n8. Patients who received systemic steroids or immunosuppressants within the previous 4 weeks of screening.\n9. Treatment that included antibiotic, antifungal, or antiparasitic medications during screening.\n10. Patients having a history of cancer (defined as malignancy), asthma, or bronchospasm.\n11. Patients not able to withdraw from treatment or need continuing immunosuppressants for example sirolimus or cyclosporine during the study period.\n12. Patients with hyperkalemia\n13. Positive pregnancy test or lactating patients.\n14. Patients with history or evidence of chemical substance abuse.\n15. Patients with a history of failure to retain enemas.\n16. Patients with Crohn's disease.\n17. Patients with HIV, Hepatitis B and Hepatitis C infection\n18. Patients who are currently using potassium sparing diuretics\n19. Patients with pre-existent renal function disorders, liver function disorders, cardiac disease, hypertension, clinically important hematological, metabolic, psychiatric, central nervous system (CNS) or pulmonary disease.\n20. Patients who participated in any other clinical or post-marketing study (not only for study drugs but also for medical devices) 30 days before signing the informed consent.\n21. Any condition which the Investigator judges to preclude safe participation in the study or to confound the evaluation of the study outcome.\n22. Uncontrolled hypertension (defined as systolic ≥140 mmHg or diastolic ≥90 mmHg) despite optimal antihypertensive treatment at screening. If blood pressure is out of range, up to 2 repeated assessments are permitted no more than 60 minutes apart.\n23. Patient with severe hepatic impairment, defined as Child Pugh Class C.","ALL",{"count":75,"type":21},150,[53],"The study will evaluate the effectiveness, safety and tolerability of tacrolimus lipid suspension for enema in adult patients with mild to moderately active ulcerative colitis who had an inadequate response or intolerance of at least 1 of aminosalicylates (5-ASAs), corticosteroids, azothiopurine, mercaptopurine and methotrexate and need an alternative therapy. There will be approximately 150 male and female subjects of 18 and 65 years of age enrolled. Patients will be randomized into two groups where Tacrolimus Lipid Suspension for Enema or Placebo (Tacrolimus-free) Lipid Suspension for Enema will be administered rectally once daily for 28 days.",[79,80],"Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate","2025-03-10",{"date":83,"type":34},"2025-03-12",{"date":85,"type":21},"2025-04",{"date":87,"type":21},"2026-04",{"name":40,"class":41},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100582765","phase-3-paclitaxel-lipid-suspension-for-patients-with-platinum-resistant-refractory-ovarian-cancer-100582765","NCT06867562","Paclitaxel Lipid Suspension for Patients with Platinum-Resistant \u002FRefractory Ovarian Cancer","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\u002FRefractory Recurrent High-grade Serous Epithelial Ovarian Cancer Including Fallopian Tube And\u002For Primary Peritoneal Cancer","Inclusion Criteria:\n\n1. The participant is willing to give written signed and dated informed consent to participate in the study.\n2. Female ≥18 years of age fulfilling all other eligibility criteria.\n3. Participants must have histopathologically\u002Fcytologically confirmed diagnosis of high-grade serous epithelial carcinoma of the ovary, fallopian tube cancer or primary peritoneal carcinoma. Non-epithelial or mixed (\\\u003C50% of the primary tumor confirmed to be high-grade serous) epithelial\u002Fnon-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.\n4. Platinum resistant or refractory disease as per standard clinical and Gynecologic Oncology Group definition. Platinum-resistant\u002Frefractory 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.\n5. 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.\n6. Have at least one measurable lesion as per the RECIST criteria (version 1.1).\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n8. Left Ventricular Ejection fraction (LVEF) ≥50% as per Echocardiography (ECHO).\n9. Participant has recovered from adverse events (baseline or ≤ 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.\n10. Participants with life expectancy of at least 6 months in the Investigator's opinion.\n11. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    * Is not a woman of childbearing potential (WOCBP) OR\n    * Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year) for at least 6 months after the last dose of IMP.\n    * 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.\n    * 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.\n    * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.\n12. Participants with adequate bone marrow, renal and hepatic function\n13. Has had prior PARP inhibitors for participants with documented breast cancer gene (BRCA) mutation (germline and\u002For somatic) or HRD status, unless the participant is not eligible for treatment with a PARP inhibitor due to precautions\u002Fintolerance, or if the treatment is not approved locally or not available due to any reasons.\n14. 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\u002Fintolerance, or if the treatment is not approved or available locally.\n15. 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.\n\nExclusion Criteria:\n\n1. 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\u002Fadjuvant setting in the first line or platinum-sensitive relapse.\n2. 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.\n3. 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.\n4. Participants who are using known strong CYP3A4 inducers, CYP3A4 inhibitors, CYP2C8 strong inhibitors, and strong inducers.\n5. 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.\n\n   Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently).\n6. Participants with clinically significant current or recent (within the past 6 months before randomization) cardiac conditions as defined below:\n\n   * Unstable angina\n   * Myocardial infarction\n   * Severe uncontrolled ventricular arrhythmias\n   * Clinically significant pericardial disease\n   * Electrocardiographic evidence of acute ischemia\n   * Participants with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable\n   * History of cardiac disease that met the NYHA Classification class 2 or greater\n   * Cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism\n7. Uncontrolled diabetes (defined as HbA1c ≥8% as per ADA) or has an active infection requiring systemic therapy.\n8. 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.\n9. Has known active central nervous system (CNS) metastases and\u002For 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.\n10. 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.\n11. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 as defined by NCI CTCAE v5.0 criteria.\n12. 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.\n13. Participants who are unwilling or unable to follow protocol requirements.\n14. 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.\n15. Prior known hypersensitivity reactions to and\u002For any of their excipients.",{"count":97,"type":21},166,[24],"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\u002Frefractory recurrent high-grade serous epithelial ovarian cancer.\n\nPaclitaxel Lipid Suspension or conventional paclitaxel will be administered intravenously at a dose level of 80 mg\u002Fm2 on Day 1, Day 8 and Day 15 of each 28 days cycle.\n\nThe primary objective is to establish the non-inferiority of Paclitaxel Lipid Suspension in comparison with conventional paclitaxel for Injection in participants with platinum-resistant\u002Frefractory recurrent advanced high-grade serous epithelial ovarian cancer including fallopian tube and\u002For primary peritoneal cancer.\n\nParticipants in both arms will be dosed with the drug until disease progression as assessed by investigator and\u002For unacceptable toxicity.",[101,102,103],"Platinum-Resistant Primary Peritoneal Carcinoma","Platinum Resistant High Grade Epithelial Ovarian Cancer","Platinum Resistant High Grade Serous Ovarian Cancer","2025-03-07",{"date":81,"type":34},{"date":85,"type":21},{"date":108,"type":21},"2026-03",{"name":40,"class":41},""]