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Активно (без набиране) Фаза 1/2

A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

Solid Tumors Harboring NTRK Fusion

The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.

Начало: 16.12.2015 Край: 30.09.2026 Възраст: до 21 г. Лечение

Australia, Canada, China +16 Bayer NCT02637687

Активно (без набиране) Фаза 4

Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

ALK Positive Malignancies

The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.

Начало: 11.12.2015 Край: 09.06.2027 Възраст: 12–100 г. Лечение

Australia, Belgium, Brazil +18 Novartis Pharmaceuticals NCT02584933

Активно (без набиране) Фаза 3

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

Rheumatoid Arthritis

The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.

Начало: 01.12.2015 Край: 30.09.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belarus +37 AbbVie NCT02629159

Активно (без набиране)

REDUCE LAP-HF RANDOMIZED TRIAL I

Heart Failure

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

Начало: 01.12.2015 Край: 01.08.2026 Възраст: от 40 г. Лечение

Australia, Belgium, Netherlands +2 Corvia Medical NCT02600234

Активно (без набиране) Фаза 3

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

Prostate Cancer

The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

Начало: 27.11.2015 Край: 31.12.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +19 Aragon Pharmaceuticals, Inc. NCT02489318

Активно (без набиране) Фаза 2

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

Breast Cancer Cholangiocarcinoma Colorectal Cancer Head and Neck Neoplasms +12

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

Начало: 19.11.2015 Край: 14.05.2026 Възраст: от 18 г. Лечение

Australia, Belgium, China +13 Hoffmann-La Roche NCT02568267

Активно (без набиране) Фаза 3

Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

Non-Small Cell Lung Cancer

This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.

Начало: 31.10.2015 Край: 31.08.2027 Възраст: от 18 г. Лечение

Australia, Belgium, China +17 Hoffmann-La Roche NCT02486718

Активно (без набиране) Фаза 3

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

Stage IB-IIIA Non-small Cell Lung Carcinoma

To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

Начало: 21.10.2015 Край: 31.01.2029 Възраст: 18–130 г. Лечение

Australia, Belgium, Brazil +22 AstraZeneca NCT02511106

Активно (без набиране) Фаза 2

Study of Tumour Focused Radiotherapy for Bladder Cancer

Bladder Cancer

Bladder cancer is the seventh most common cancer in the UK, with 10,399 new cases diagnosed in 2011. In a quarter of these cases the cancer has infiltrated the muscular wall of the bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually treated either with surgical removal of the bladder, or daily radiotherapy treatment (high strength xrays which kill cells), given every day for 4 or 7 weeks. RAIDER will investigate methods which have the potential to improve how well this radiotherapy works. RAIDER is based on a study of novel radiotherapy techniques which was conducted at a single UK NHS Trust. Bladder radiotherapy is normally delivered using a single plan throughout treatment and treats the whole bladder with the same radiotherapy dose. In adaptive radiotherapy the delivery plan is chosen from 3 possible plans. In cancer (tumour) focused radiotherapy, the highest dose of the radiotherapy is aimed at the tumour within the bladder. In RAIDER, at least 240 participants with muscle invasive bladder cancer will be in one of 3 treatment groups: 1. standard whole bladder radiotherapy 2. standard dose tumour focused adaptive radiotherapy 3. dose escalated tumour boost adaptive radiotherapy Participants will visit the hospital 4 weeks, 3, 6, 9, 12, 18 and 24 months after radiotherapy and annually thereafter to check whether the cancer has returned and to receive treatment for any symptoms they may be experiencing. RAIDER aims to confirm in a multicentre setting that novel techniques allow a higher radiotherapy dose than standard to be reliably targeted at the tumour within the bladder and to check that the long term side effects of the treatment are acceptable. If this is the case, results of RAIDER will be used to develop a study to establish whether dose escalated radiotherapy is better at treating bladder cancer than standard dose.

Начало: 21.10.2015 Край: 01.03.2029 Възраст: от 16 г. Лечение

Australia, New Zealand, United Kingdom Institute of Cancer Research, United Kingdom NCT02447549

Активно (без набиране) Фаза 3

Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)

Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

The main objectives of the PATHOS study are: To assess whether swallowing function can be improved following transoral resection of HPV-positive OPSCC, by reducing the intensity of adjuvant treatment protocols. The aim is to personalise treatment, based on disease biology (HPV status and pathology findings), to optimise patient outcomes. To demonstrate the non-inferiority of reducing the intensity of adjuvant treatment protocols in terms of overall survival in the reduced intensity treatment arms.

Начало: 01.10.2015 Край: 01.04.2028 Възраст: от 18 г. Лечение

Australia, France, Germany +2 Lisette Nixon NCT02215265

Активно (без набиране)

Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking

Neoplasms Lung Neoplasms

A research study into a new technology for adjustment of the radiotherapy beam to account for movement of lung tumours as the patient breathes during radiotherapy.

Начало: 01.09.2015 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia Royal North Shore Hospital NCT02514512

Активно (без набиране) Фаза 4

HeadStart4: Newly Diagnosed Children (

Medulloblastoma Central Nervous System Embryonal Tumors

This is a prospective randomized clinical trial, to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.

Начало: 01.09.2015 Край: 01.12.2030 Възраст: до 10 г. Лечение

Canada, New Zealand, United States Parth Patel NCT02875314

Активно (без набиране) Фаза 3

Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Germ Cell Tumors

Germ Cell Tumor Teratoma Choriocarcinoma Germinoma +7

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, 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. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

Начало: 06.08.2015 Край: 01.06.2031 Възраст: от 14 г. Лечение

Australia, Belgium, Denmark +8 Alliance for Clinical Trials in Oncology NCT02375204

Активно (без набиране) Фаза 3

PALbociclib CoLlaborative Adjuvant Study

Breast Cancer

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.

Начало: 01.08.2015 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +15 Alliance Foundation Trials, LLC. NCT02513394

Активно (без набиране) Фаза 3

Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

Chronic Lymphocytic Leukemia

This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.

Начало: 28.07.2015 Край: 03.01.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Denmark +11 Acerta Pharma BV NCT02477696

Активно (без набиране) Фаза 3

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia

Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA

This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.

Начало: 21.07.2015 Край: 30.06.2029 Възраст: 12–21 г. Лечение

Australia, Canada, New Zealand +3 Children's Oncology Group NCT02339740

Активно (без набиране) Фаза 3

Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)

Non-Small-Cell Lung Carcinoma NSCLC

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

Начало: 21.07.2015 Край: 31.12.2026 Възраст: 18–130 г. Лечение

Australia, Belgium, Canada +14 AstraZeneca NCT02453282

Активно (без набиране) Фаза 4

A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)

Independent Living Disability Free Survival Elderly Healthy

The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with placebo will prolong disability free survival and reduce major cardiovascular events amongst healthy elderly people (≥70 years).

Начало: 01.07.2015 Край: 01.12.2025 Възраст: от 70 г. Превенция

Australia Monash University NCT02099123

Активно (без набиране)

Micra Transcatheter Pacing System Post-Approval Registry

Bradycardia

Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release. The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

Начало: 01.07.2015 Край: 01.04.2027

Belgium, Canada, Czechia +18 Medtronic NCT02536118

Активно (без набиране)

LEGION Hinge Safety and Efficacy Study

Knee Arthroplasty, Total

The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).

Начало: 30.06.2015 Край: 01.08.2028 Възраст: 18–80 г.

Australia, Belgium, Canada +2 Smith & Nephew, Inc. NCT02445443

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