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Active (not recruiting) Phase 3

Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma

Ganglioneuroblastoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Neuroblastoma

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

Начало: 08.08.2014 Край: 30.09.2026 Възраст: до 18 г. Treatment

Australia, Canada, New Zealand +3 Children's Oncology Group NCT02176967

Active (not recruiting)

POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer

Breast Cancer

POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial. Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years. Stratification: Institution, Age (\

Начало: 01.08.2014 Край: 31.12.2026 Възраст: от 18 г. Treatment

Australia, New Zealand, United Kingdom University Hospitals of Derby and Burton NHS Foundation NCT02401685

Active (not recruiting) Phase 3

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

Breast Neoplasms

The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

Начало: 22.07.2014 Край: 01.12.2027 Възраст: от 18 г. Treatment

Australia, Belgium, Canada +16 Eli Lilly and Company NCT02107703

Active (not recruiting)

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Aortic Valve Stenosis

The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.

Начало: 01.05.2014 Край: 01.12.2026 Възраст: от 21 г. Treatment

Australia, United States Abbott Medical Devices NCT02000115

Active (not recruiting) Phase 3

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Начало: 22.04.2014 Край: 28.05.2029 Възраст: 18–130 г. Treatment

Argentina, Australia, Belgium +18 AstraZeneca NCT02032823

Active (not recruiting) Phase 2/3

Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

Epstein-Barr Virus Infection Stage II Nasopharyngeal Carcinoma Stage III Nasopharyngeal Carcinoma Stage IVA Nasopharyngeal Carcinoma +1

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

Начало: 21.04.2014 Край: 01.02.2031 Възраст: от 18 г. Treatment

Australia, Canada, China +5 NRG Oncology NCT02135042

Active (not recruiting) Phase 3

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

Cholangiocarcinoma Gall Bladder Carcinoma

This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC.

Начало: 01.04.2014 Край: 01.12.2025 Възраст: от 18 г. Treatment

Australia, Denmark, Italy +3 Universitätsklinikum Hamburg-Eppendorf NCT02170090

Active (not recruiting) Phase 3

Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

Prostatic Neoplasms

The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.

Начало: 01.03.2014 Край: 30.06.2027 Възраст: от 18 г. Treatment

Australia, Canada, Ireland +3 University of Sydney NCT02446405

Active (not recruiting) Phase 3

Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer

Prostatic Neoplasms

The purpose of this study is to determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk of recurrence.

Начало: 01.03.2014 Край: 01.03.2026 Възраст: от 18 г. Treatment

Australia, Belgium, Ireland +5 University of Sydney NCT02446444

Active (not recruiting)

The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study

Colonic Polyps

To enhance understanding of the risk factors for AMN, improve lesion assessment and prediction of submucosal invasive cancer, improve endoscopic resection efficacy, reduce complications of WF-EMR and improve the understanding of the progression of large lesions to cancer

Начало: 01.01.2014 Край: 01.01.2027 Възраст: 18–99 г.

Australia Professor Michael Bourke NCT02000141

Active (not recruiting)

Long-term Follow-up of Subjects With Transfusion-Dependent β-Thalassemia (TDT) Treated With Ex Vivo Gene Therapy

Transfusion-dependent Beta-Thalassemia

This is a multi-center, long-term safety and efficacy follow-up study for subjects with transfusion-dependent β-thalassemia (TDT) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored parent clinical studies. After completing the parent clinical studies (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.

Начало: 01.01.2014 Край: 01.11.2035 Възраст: до 50 г.

Australia, France, Germany +5 Genetix Biotherapeutics Inc. NCT02633943

Active (not recruiting) Phase 3

Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

Pulmonary Emphysema in Alpha-1 PI Deficiency

This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.

Начало: 01.11.2013 Край: 01.01.2027 Възраст: 18–70 г. Treatment

Argentina, Australia, Brazil +13 Grifols Therapeutics LLC NCT01983241

Active (not recruiting) Phase 1/2

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

Breast Cancer

The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4). The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6. Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.

Начало: 22.10.2013 Край: 26.02.2027 Възраст: 18–100 г. Treatment

Australia, France, Italy +5 Novartis Pharmaceuticals NCT01872260

Active (not recruiting) Phase 3

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

Prostatic Neoplasms

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Начало: 14.10.2013 Край: 31.12.2027 Възраст: от 18 г. Treatment

Australia, Belgium, Canada +20 Aragon Pharmaceuticals, Inc. NCT01946204

Active (not recruiting) Phase 3

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

Начало: 25.09.2013 Край: 31.12.2025 Възраст: 18–130 г. Treatment

Argentina, Australia, Belgium +21 AstraZeneca NCT01933932

Active (not recruiting) Phase 3

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

Platinum Sensitive BRCA Mutated Relapsed Ovarian Cancer Following Complete or Partial Response to Platinum Based Chemotherapy

A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.

Начало: 03.09.2013 Край: 31.12.2025 Възраст: 18–130 г. Treatment

Australia, Belgium, Brazil +14 AstraZeneca NCT01874353

Active (not recruiting) Phase 3

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Newly Diagnosed Advanced Ovarian Cancer FIGO Stage III-IV BRCA Mutation +3

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Начало: 26.08.2013 Край: 29.08.2028 Възраст: 18–130 г. Treatment

Australia, Brazil, Canada +12 AstraZeneca NCT01844986

Active (not recruiting) Phase 3

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Multiple Sclerosis

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

Начало: 26.07.2013 Край: 18.02.2030 Възраст: 10–17 г. Treatment

Australia, Brazil, Bulgaria +21 Novartis Pharmaceuticals NCT01892722

Active (not recruiting) Phase 2

A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Medulloblastoma

Historically, medulloblastoma treatment has been determined by the amount of leftover disease present after surgery, also known as clinical risk (standard vs. high risk). Recent studies have shown that medulloblastoma is made up of distinct molecular subgroups which respond differently to treatment. This suggests that clinical risk alone is not adequate to identify actual risk of recurrence. In order to address this, we will stratify medulloblastoma treatment in this phase II clinical trial based on both clinical risk (low, standard, intermediate, or high risk) and molecular subtype (WNT, SHH, or Non-WNT Non-SHH). This stratified clinical and molecular treatment approach will be used to evaluate the following: * To find out if participants with low-risk WNT tumors can be treated with a lower dose of radiation to the brain and spine, and a lower dose of the chemotherapy drug cyclophosphamide while still achieving the same survival rate as past St. Jude studies with fewer side effects. * To find out if adding targeted chemotherapy after standard chemotherapy will benefit participants with SHH positive tumors. * To find out if adding new chemotherapy agents to the standard chemotherapy will improve the outcome for intermediate and high risk Non-WNT Non-SHH tumors. * To define the cure rate for standard risk Non-WNT Non-SHH tumors treated with reduced dose cyclophosphamide and compare this to participants from the past St. Jude study. All participants on this study will have surgery to remove as much of the primary tumor as safely possible, radiation therapy, and chemotherapy. The amount of radiation therapy and type of chemotherapy received will be determined by the participant's treatment stratum. Treatment stratum assignment will be based on the tumor's molecular subgroup assignment and clinical risk. The participant will be assigned to one of three medulloblastoma subgroups determined by analysis of the tumor tissue for tumor biomarkers: * WNT (Strata W): positive for WNT biomarkers * SHH (Strata S): positive for SHH biomarkers * Non-WNT Non-SHH, Failed, or Indeterminate (Strata N): negative for WNT and SHH biomarkers or results are indeterminable Participants will then be assigned to a clinical risk group (low, standard, intermediate, or high) based on assessment of: * How much tumor is left after surgery * If the cancer has spread to other sites outside the brain \[i.e., to the spinal cord or within the fluid surrounding the spinal cord, called cerebrospinal fluid (CSF)\] * The appearance of the tumor cells under the microscope * Whether or not there are chromosomal abnormalities in the tumor, and if present, what type (also called cytogenetics analysis)

Начало: 23.06.2013 Край: 13.10.2031 Възраст: 3–39 г. Treatment

Australia, Canada, New Zealand +1 St. Jude Children's Research Hospital NCT01878617

Active (not recruiting) Phase 2

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma

Unresectable Pleural or Peritoneal Malignant Mesothelioma

This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.

Начало: 17.05.2013 Край: 30.06.2026 Възраст: 18–99 г. Treatment

Australia, Belgium, Canada +15 MedImmune LLC NCT01843374

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