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Активно (без набиране) Фаза 3

Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line

Endometrial Cancer

Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.

Начало: 15.04.2022 Край: 01.10.2029 Възраст: от 18 г. Лечение

Australia, Canada, France +7 ARCAGY/ GINECO GROUP NCT05201547

Активно (без набиране) Фаза 3

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Advanced Gastrointestinal Stromal Tumors Metastatic Cancer

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 442 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. Additionally, a drug-drug interactions substudy will investigate the potential for CGT9486 to be a CYP3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST.

Начало: 14.04.2022 Край: 01.09.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +18 Cogent Biosciences, Inc. NCT05208047

Активно (без набиране) Фаза 3

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

Prostatic Neoplasms Neoplasm Metastasis Urogenital Neoplasms Physiological Effects of Drugs +13

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

Начало: 14.04.2022 Край: 01.10.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +21 Eli Lilly and Company NCT05288166

Активно (без набиране) Фаза 2

The ASCEND Study: Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma Metastatic Pancreatic Cancer

The purpose of the ASCEND clinical trial is to measure the effect of adding LSTA1 (certepetide), compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. The study will assess the duration which the cancer remained stable or improved, the number of patients who responded to treatment, overall survival, side effects and quality of life.

Начало: 13.04.2022 Край: 01.10.2025 Възраст: от 18 г. Лечение

Australia, New Zealand Australasian Gastro-Intestinal Trials Group NCT05042128

Активно (без набиране)

Defining Endpoints in Becker Muscular Dystrophy

Becker Muscular Dystrophy Muscular Dystrophies Muscular Dystrophy in Children Muscular Dystrophy, Becker

This is a 24-month, observational study of 50 participants with Becker muscular dystrophy (BMD)

Начало: 13.04.2022 Край: 01.05.2026 Възраст: от 6 г.

New Zealand, United Kingdom, United States Virginia Commonwealth University NCT05257473

Активно (без набиране) Фаза 3

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Hepatic Encephalopathy

Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.

Начало: 07.04.2022 Край: 01.09.2025 Възраст: 18–85 г. Превенция

Australia, Canada, Puerto Rico +1 Bausch Health Americas, Inc. NCT05071716

Активно (без набиране)

Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children

Long Bone Fractures

International registry to collect prospective treatment and outcomes data on specific, key non-pathological fractures in children with open physes. Data will be collected during follow-up visits according to standard of care at 3 to 8 weeks, 3, 6, 12 and 24 months

Начало: 05.04.2022 Край: 31.12.2028 Възраст: до 18 г.

Australia, Canada, Chile +9 AO Innovation Translation Center NCT04207892

Активно (без набиране) Фаза 3

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

Polycythemia Vera

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

Начало: 01.04.2022 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +15 Protagonist Therapeutics, Inc. NCT05210790

Активно (без набиране) Фаза 3

Olorofim Aspergillus Infection Study

Invasive Aspergillosis

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

Начало: 31.03.2022 Край: 01.11.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +17 F2G Biotech GmbH NCT05101187

Активно (без набиране) Фаза 2

Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

Diffuse Cutaneous Systemic Sclerosis Interstitial Lung Disease

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

Начало: 29.03.2022 Край: 31.07.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +17 Prometheus Biosciences, Inc., a subsidiary of Merck & C NCT05270668

Активно (без набиране) Фаза 3

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Multiple Myeloma

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Начало: 25.03.2022 Край: 31.10.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +22 Pfizer NCT05317416

Активно (без набиране) Фаза 3

Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)

Prostate Cancer

This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival and/or the radiographic progression free survival of study participants.

Начало: 25.03.2022 Край: 04.03.2026 Възраст: 18–130 г. Лечение

Australia, Belgium, Brazil +19 AstraZeneca NCT05348577

Активно (без набиране) Фаза 3

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)

Small Cell Lung Carcinoma

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Начало: 24.03.2022 Край: 07.06.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +20 Merck Sharp & Dohme LLC NCT05224141

Активно (без набиране)

Prostate Imaging Using MRI +/- Contrast Enhancement

Prostate Cancer

This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer. This means that we are comparing MRI scans that requires injection of IV contrast (the current standard practice) versus MRI scans that can be performed without IV contrast in the detection of prostate cancer.

Начало: 22.03.2022 Край: 01.03.2025 Възраст: от 18 г. Диагностика

Argentina, Australia, Belgium +11 University College, London NCT04571840

Активно (без набиране) Фаза 1

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

Neoplasms

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of remzistotug in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.

Начало: 22.03.2022 Край: 31.08.2027 Възраст: от 18 г. Лечение

Australia, Canada, China +6 GlaxoSmithKline NCT05277051

Активно (без набиране) Фаза 1/2

A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis

Osteoarthritis, Knee

The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of ICM-203 or matching placebo into the knee of subjects with mild to moderate knee osteoarthritis (OA).

Начало: 17.03.2022 Край: 01.12.2026 Възраст: 50–80 г. Лечение

Australia ICM Biotech Australia Pty Ltd. NCT04875754

Активно (без набиране)

COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

Multivessel Coronary Artery Disease Ischemia Vulnerable Plaque Coronary Artery Disease

The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation.

Начало: 16.03.2022 Край: 31.12.2026 Възраст: 30–80 г. Лечение

Australia, Canada, Denmark +14 Diagram B.V. NCT05333068

Активно (без набиране) Фаза 3

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

Immunoglobulin A Nephropathy

To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy

Начало: 15.03.2022 Край: 30.12.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +27 Otsuka Pharmaceutical Development & Commercialization, NCT05248646

Активно (без набиране) Фаза 3

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

Carcinoma, Renal Cell

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).

Начало: 15.03.2022 Край: 28.09.2029 Възраст: от 18 г. Лечение

Australia, Brazil, Bulgaria +29 Merck Sharp & Dohme LLC NCT05239728

Активно (без набиране) Фаза 3

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

Gastric Cancer Gastroesophageal Junction Adenocarcinoma

The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

Начало: 14.03.2022 Край: 29.01.2027 Възраст: 18–100 г. Лечение

Argentina, Australia, Belgium +24 Amgen NCT05111626

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