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Ovarian Neoplasms clinical trials

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NCT ID: NCT03551171 Completed - Ovarian Cancer Clinical Trials

The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer

Start date: December 19, 2017
Phase: Phase 1
Study type: Interventional

Niraparib is a potent and highly selective PARP-1/-2 inhibitor. The primary objective of this trial is to evaluate the pharmacokinetic (PK) properties of ZL-2306 (niraparib) and its metabolite M1 in patients from Mainland China with ovarian cancer, following a single and multiple oral administration of the study drug at the indicated dose (300mg, 200mg or 100mg), once a day.

NCT ID: NCT03543462 Completed - Ovarian Cancer Clinical Trials

Diaphragmatic Resection And Gynecological Ovarian Neoplasm

DRAGON
Start date: March 20, 2018
Phase: Phase 4
Study type: Interventional

Prospective randomized phase IV study aimed to value the impact of diaphragmatic surgery and the useful of intra-operatory thoracic drain in advanced ovarian cancer. Considering the fact that the diaphragmatic surgery could contribute with the incidence of post-operatory morbidity. The study is aimed to value the role of thoracic drain in post-operative outcomes as hospital stay, time to chemotherapy, drugs use and eventual interventions.

NCT ID: NCT03519165 Completed - Ovarian Cancer Clinical Trials

Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery

RIGoROCS
Start date: June 2016
Phase: N/A
Study type: Interventional

This is a single center prospective randomized controlled study comparing the postoperative outcome after cytoreductive surgery in ovarian cancer patient after using restrictive or individualized goal-directed fluid replacement strategy (GDT). Aim of this study will be to test the hypothesis that intra-operative SVV-guided fluid optimization during ovarian cancer cytoreductive surgery: 1. reduces the postoperative length of hospital stay, 2. cost-effective, 3. GDT will be more beneficial in cases of PDS compared to IDS or cytoreductive procedures of shorter duration. 4. GDT improves intraoperative tissue perfusion/ oxygenation and improves immediate postoperative morbidity. Intra-operatively fluid of choice in both groups will be lactate-free crystalloid at 1.0 ml/kg/h for maintenance and gelofusine for fluid bolus of 3ml/kg over 5 minutes. In group C intraoperative fluid therapy will include maintenance fluid and replacement of the surgical loss. Aim will be to maintain MAP > 65 mmHg, CVP 8-12 cm H2O and urine output > 0.5 ml/kg/h. In group G intraoperative fluid therapy will be targeted to SVV <13%, SVI > 35ml/m2/ beat, SVRI more than equal to 1900 dynes-sec/cm-5/m2 in addition to clinical parameters like MAP, CVP and urine output. Primary outcome will be length of hospital stay (LOS). Secondary outcomes will be cost of surgical treatment episode (admission till fit to discharge), postoperative morbidity survey (POMS) and 30 day morbidity and mortality.

NCT ID: NCT03509636 Completed - Ovarian Cancer Clinical Trials

A Study of Fluzoparib(SHR-3162)in BRCA1/2-mutant Relapsed Ovarian Cancer

Start date: April 4, 2018
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib (SHR-3162)in BRCA1/2-mutant Relapsed Ovarian Cancer.

NCT ID: NCT03508011 Completed - Breast Cancer Clinical Trials

A Study of IMP4297 in Patients With Advanced Solid Tumors

Start date: August 23, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase I, first-in-human, open-label, dose-escalation study of IMP4297 administered orally once every day to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Patients with advanced breast cancer, ovarian cancer or prostate cancer are preferred. There are two stages to this study: a dose-escalation stage and a dose-expansion stage.

NCT ID: NCT03507543 Completed - Breast Cancer Clinical Trials

The Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors

Start date: February 3, 2017
Phase: Phase 1
Study type: Interventional

This is a phase 1, First-In-Human, open label study, trialing a new PARP (poly-ADP ribose polymerase) inhibitor medication IMP4297 in participants with advanced solid tumour.

NCT ID: NCT03505307 Completed - Ovarian Cancer Clinical Trials

Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

Start date: May 21, 2018
Phase:
Study type: Observational

[Objectives] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use. 1. ADR development in actual clinical use 2. Factors which may affect safety and efficacy 3. ADRs not expected from "Precautions for Use"

NCT ID: NCT03491033 Completed - Clinical trials for Advanced-stage Ovarian Cancer

Genomic Profiling of the Residual Disease of Advanced-stage Ovarian Cancer After Neoadjuvant Chemotherapy

Start date: August 28, 2017
Phase:
Study type: Observational

Tumor response to NAC predicts survival and can be considered a surrogate prognostic marker. Three tiered chemotherapy response score (CRS) of omental tissue sections showed a significant association with survival. In patients with CRS 1 or 2, NAC selects a subpopulation of chemotherapy resistant tumor cells. This study will examine comprehensive molecular analyses on the residual disease of 104 clinically defined high-grade serous carcinoma after NAC, including next-generation sequencing on 14 matched pretreatment biopsies. This information together with immune marker expression and BRCA expression, will provide a unique opportunity to guide biomarker-driven adjuvant studies targeting these chemotherapy-resistant tumor cells.

NCT ID: NCT03480750 Completed - Clinical trials for Fallopian Tube Cancer

Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer

Trientine
Start date: September 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Epithelial ovarian cancer (EOC) is the leading cause of gynecological malignancy-related deaths worldwide and is a substantial health threat to women. Many patients eventually develop chemoresistant relapsed disease and die despite surgery and combination chemotherapy. Progress in improving the survival in EOC has been slow, despite significant advances in treatment over the past 25 years. Tubal cancer and peritoneal cancer are thought to be similar in their origin, characteristics and treatment strategies. Based upon basic and animal studies, it is thought that copper chelators overcome platinum resistance. Thus, Trientine combined with carboplatin has been used to treat human cancers. The adverse effects (AEs) are acceptable in previously heavily-treated recurrent ovarian cancer patients, however, the treatment responses are limited. Therefore, here the investigators conduct a phase I trial of Trientine®, pegylated doxorubicin and carboplatin to find the dose-limited toxicities, and maximal toxicity dosage, and to explore whether the combination is applicable in epithelial ovarian, tubal and peritoneal cancers.

NCT ID: NCT03471572 Completed - Ovarian Cancer Clinical Trials

Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India

BRCA
Start date: March 22, 2018
Phase:
Study type: Observational

This is a non-interventional, cross-sectional, multicentre, observational study planned to be conducted at 15 sites across all geographical regions of India. The study targets to enrol 240 patients with approximately 16 patients from each site. Written approval of Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) and written informed consent from willing patients will be obtained prior to the start of the study.