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NCT ID: NCT03193281 Not yet recruiting - Clinical trials for Chronic Myeloid Leukemia

KISS Study: Kinase Inhibition With Sprycel Start up

KISS
Start date: July 2017
Phase: Phase 2
Study type: Interventional

Chronic myeloid leukaemia (CML) is due to a chromosomal abnormality in white blood cells which results in abnormal multiplication. CML in its earlier, slower growing chronic phase (CP) is well controlled by the tyrosine kinase inhibitor (TKI) drug imatinib, which targets the consequences of the chromosomal abnormality, inducing a response and subsequent remission (as measured using molecular techniques on patient blood or bone marrow samples in the lab). Dasatinib, a newer TKI drug, similar in design to imatinib, gives a more rapid molecular response, however the long term side-effects are less known than imatinib. This study will investigate the efficacy and safety of a treatment plan for patients with newly diagnosed CML-CP, where dasatinib will be used to more rapidly induce a molecular response (MR3.0) within 12 months, after which imatinib will be used to maintain the CML in that remission. It is hypothesised that imatinib is safe and effective in maintaining MR3.0 in patients with CML who achieve MR3.0 at 12 months following initial induction therapy with dasatinib.

NCT ID: NCT03181633 Not yet recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Long-term Treatment Study of ACH-0144471 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start date: June 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate long term safety and efficacy of ACH-0144471 in patients with PNH who have demonstrated clinical benefit from ACH-0144471 in Clinical Study ACH471-100. This study is designed to include up to 12 patients.

NCT ID: NCT03171155 Not yet recruiting - Clinical trials for Percutaneous Closure of Arteriotomy in Common Femoral Artery

Clinical Study of the Medeon Biodesign XPro™

Start date: May 30, 2017
Phase: N/A
Study type: Interventional

To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.

NCT ID: NCT03159416 Not yet recruiting - Renal Impairment Clinical Trials

A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)

Start date: June 2017
Phase: Phase 1
Study type: Interventional

This study is a Phase I, single-dose, open-label trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC) injection in participants with mild, moderate, and severe renal impairment compared to participants with normal renal function.

NCT ID: NCT03158636 Recruiting - Gynecologic Cancer Clinical Trials

Profiling of Oncology Patients as Part of Clinical Care and Research

PROSPER
Start date: September 2016
Phase: N/A
Study type: Observational [Patient Registry]

The era of precision medicine is an exciting time for clinicians, scientists and patients alike. The increasing appreciation and identification of specific mutations that drive cancers, leaves us on the threshold of a new era in which biomarkers will be used to direct targeted agents to only those patients most likely to respond. The potential medical and scientific benefits of such a personalised approach to cancer therapy are immense. However, a number of barriers challenge successful implementation of this approach of which spatial and temporal heterogeneity are a major concern. Gynaecological cancers are a major cause of mortality and morbidity internationally. In Auckland 150 new patients with ovarian, endometrial or cervical cancer are seen by a medical oncologist each year. In general, when these diseases recur, there are few effective therapeutic options and prognosis is poor. Better therapeutic targets and treatments are an unmet need across these tumour types with treatment paradigms still based upon platinum based therapy. PROSPER (Profiling of Oncology Patients as part of Clinical care and Research) will investigate the evolution of gynaecological cancers over time and in response to treatment to develop better biomarkers to guide treatment decisions and ultimately improve patient outcomes. Biopsies at relapse will be collected and profiled with a 580 cancer gene panel. Circulating tumour DNA will be collected and analysed alongside biopsies as a potential non-invasive alternative. Linking genomic and clinical data will allow us to learn more to begin to change our paradigm of care.

NCT ID: NCT03156413 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea

Start date: May 2017
Phase: N/A
Study type: Interventional

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

NCT ID: NCT03155997 Not yet recruiting - Breast Cancer Clinical Trials

A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer

monarchE
Start date: June 28, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

NCT ID: NCT03139604 Recruiting - Clinical trials for Acute Graft-versus-host Disease

GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

Start date: June 8, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

NCT ID: NCT03135262 Recruiting - Follicular Lymphoma Clinical Trials

A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Start date: June 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with idasanutlin and venetoclax in participants with R/R FL and obinutuzumab or rituximab in combination with idasanutlin and venetoclax in participants with R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase II doses (RP2Ds) and regimen for idasanutlin and venetoclax in combination with obinutuzumab for FL participants and in combination with rituximab for DLBCL participants.

NCT ID: NCT03133377 Not yet recruiting - Clinical trials for Critically Ill, Mechanically Ventilated

Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

TEAM(III)
Start date: May 2017
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the effect of early activity and mobilisation during prolonged IMV on the composite outcome "days alive and at home to day 180". The effect of the intervention on mortality, physical, cognitive and Psychological function at 180 days, as well as cost-effectiveness of the intervention, will also be evaluated. The study will also explore process of care measures and baseline physiology and ICU mobility outcomes. The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and mobilisation increases the number of days alive and at home to day 180 when compared with standard care.