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Ovarian Cancer clinical trials

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NCT ID: NCT05043402 Not yet recruiting - Ovarian Cancer Clinical Trials

A Study of Navicixizumab in Patients With Platinum Resistant Ovarian Cancer

Start date: November 30, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, open-label, 2-stage, multicenter study of navicixizumab with or without paclitaxel compared with paclitaxel monotherapy in patients with platinum-resistant advanced epithelial ovarian cancer and specific biomarkers, as measured by the proprietary and validated Xerna™ TME Panel biomarker assay. Eligible patients must have received at least 2 prior regimens but not more than 5 prior regimens, including treatment with a monoclonal antibody angiogenesis inhibitor (e.g., bevacizumab), must be considered platinum-resistant, and must be considered appropriate to receive single-agent paclitaxel chemotherapy as a next line of therapy. All patients must be willing and able to provide a formalin-fixed paraffin embedded (FFPE) archive or core tumor sample collected during screening for classification as B+ or B- biomarker status based on RNA expression data from the Xerna™ TME Panel biomarker assay. The co-primary efficacy endpoints are ORR by RECIST v1.1 and PFS (as assessed by blinded independent radiological review [BIRR]) analyzed at different timepoints. Analysis of the ORR primary efficacy endpoints will occur at the end of Stage 1 and at the end of Stage 2; the PFS primary efficacy endpoint will be analyzed at the end of Stage 2.

NCT ID: NCT04911114 Not yet recruiting - Ovarian Cancer Clinical Trials

Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer

BE-BALANCED
Start date: June 15, 2021
Phase: N/A
Study type: Interventional

This study will explore the feasibility (suitability), efficacy (research-setting outcomes), and participant satisfaction of a virtually-supervised 12-week exercise and diet intervention for women with ovarian cancer. It will include exercise, behavior change strategies, and guidance around healthy eating. Participants will be instructed and supervised virtually in two exercise sessions weekly for 12 weeks by a professional trained to deliver the program. An additional 1 exercise session per week, completed independently, will be added from weeks 4-12 of the program. Finally participants will participate in two separate virtual group nutrition sessions. Assessments will occur at baseline, end-of-intervention, and 6 months post-baseline.

NCT ID: NCT04828616 Not yet recruiting - Ovarian Cancer Clinical Trials

Study of DP303c Injection in Patients With Advanced Ovarian Cancer

Start date: July 2021
Phase: Phase 2
Study type: Interventional

This study is an open-label, multicentre, phase II study to evaluate the efficacy and safety of of DP303c injection in patients with HER2-expressing advanced ovarian cancer.

NCT ID: NCT04812938 Not yet recruiting - Ovarian Cancer Clinical Trials

Exploiting Pathogenic Tp53 Mutation for Early Diagnosis of Ovarian Cancer by Mean of Papanicolau Test

PAPAudit
Start date: April 12, 2021
Phase:
Study type: Observational

The aim of the project is to corroborate them on a large retrospective cohort of HGS-EOC and confirm the possibility of identify TP53 mutations in high grade endometrioid tumors. This will consequently allow to confirm the previous results and define with a greater precision the temporal windows in which it will be possible to detect, through the TP53 analysis, tumor material by vaginal swab sampling. The results of the study will be the first step of a multiphase prospective validation program for the development of a novel approach for early diagnosis of EOC.

NCT ID: NCT04661696 Not yet recruiting - Ovarian Cancer Clinical Trials

Efficacy and Safety of Paclitaxel (Albumin-bound) Combination With Carboplatin in Ovarian Cancer.

Start date: December 9, 2020
Phase: Phase 2
Study type: Interventional

Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. The majority of ovarian cancer patients with standardized treatment, including tumor cell reduction and postoperatively platinum-based combination chemotherapy, will still experience tumor recurrence and multiple recurrences within 6-18 months.With the increase in the number of recurrences, the intertherapeutic period will shorten and eventually drug resistance will emerge.The purpose of treatment for recurrent ovarian cancer is mainly to improve the quality of life of patients and prolong survival. CSPC OUYI PHARMACEUTICAL CO., LTD has successfully developed Paclitaxel (Albumin-Bound) and the bioequivalence test results show good consistency with Abraxane.To evaluate the efficacy and safety of Paclitaxel (Albumin-Bound) combination with carboplatin in Chinese patients with platinum-sensitive recurrent ovarian cancer, this clinical study is planned.

NCT ID: NCT04640480 Not yet recruiting - Breast Cancer Clinical Trials

Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors

Start date: June 21, 2024
Phase: Phase 1
Study type: Interventional

SNB-101 is a novel nano-particle formulation of SN-38, the active metabolite of irinotecan(CPT-11). Study SNB101P01 is a multicenter, open-label, dose escalation, phase 1 study of SNB 101 with its active ingredient SN-38, in participants with advanced solid tumors. Dose escalation will occur using a modified accelerated titration design (ATD). All participants will receive SNB 101 in different cohorts. SNB 101 will be administered intravenously to participants on day 1 and day 15 of each 28 day treatment cycle until progressive disease, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. A Safety Review Committee will determine dose escalation, de-escalation, and modification and the MTD/RP2D based on DLTs and other safety information.

NCT ID: NCT04627740 Not yet recruiting - Ovarian Cancer Clinical Trials

Anti-ALPP CAR-T Cells Immunotherapy for Ovarian and Endometrial Cancer

Start date: December 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and efficacy of anti-ALPP chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with ALPP-positive metastatic ovarian and endometrial cancer.

NCT ID: NCT04520139 Not yet recruiting - Ovarian Cancer Clinical Trials

Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT

Start date: December 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).

NCT ID: NCT04451369 Not yet recruiting - Ovarian Cancer Clinical Trials

Connected Prehabilitation Program During Neo Adjuvant Chemotherapy

TRAINING
Start date: May 2021
Phase: N/A
Study type: Interventional

NACT is a heavy oncologic treatment, which can impair functional capacity, nutritional and emotional status. These three impairments are often ignored and not taken into account in the pre-therapeutic evaluations but are correlated with postoperative morbidity and mortality after major surgery. Recently, a prehabilitation before surgery, including physical, nutritional and psycho-social support, has been defined. From a literature review, the maximum oxygen uptake (VO2 max) seems to constitute a strong evaluation factor reflecting physical fitness, easily measured with a cardiopulmonary exercise test (CPET) at maximal effort. Several studies have shown beneficial effects of trimodal prehabilitation programs on postoperative functional capacity, return to daily activities and pain relief. Home-based program and connected devices may improve the feasibility and the compliance to this program. The hypothesis of this study is that performing a connected supervised home-based and patient-tailored multimodal prehabilitation program from diagnosis to surgery (with or without ERAS program) during NACRT, for patients managed for ovarian cancer, will limit physical fitness alteration and will positively affect postoperative outcomes. Our study consists in an early and multidimensional (combining nutritional, physical, emotional and medical support) prehabilitation program during NACT for patients with ovarian cancer, in order to limit physical alteration before surgical treatment, and therefore improve postoperative outcomes. It will include a home-based prehabilitation program, in order to allow care access to all eligible patients.

NCT ID: NCT04383977 Not yet recruiting - Ovarian Cancer Clinical Trials

Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant Ovarian Cancer

Start date: May 2020
Phase: Phase 2
Study type: Interventional

The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) or apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with apatinib (375 mg qd).