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NCT ID: NCT01865747 Completed - Clinical trials for Renal Cell Carcinoma

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma

METEOR
Start date: June 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

NCT ID: NCT01864746 Completed - Breast Cancer Clinical Trials

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

PENELOPE-B
Start date: October 30, 2013
Phase: Phase 3
Study type: Interventional

The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

NCT ID: NCT01861002 Completed - Clinical trials for Lymphoblastic Leukemia, Acute, Childhood

A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML

Start date: May 22, 2013
Phase: Phase 1
Study type: Interventional

This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary treatment or who relapsed.

NCT ID: NCT01857206 Completed - Influenza Clinical Trials

Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Start date: May 2013
Phase: Phase 3
Study type: Interventional

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

NCT ID: NCT01856309 Completed - Clinical trials for Arthritis, Rheumatoid

Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

SIRROUND-LTE
Start date: August 7, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.

NCT ID: NCT01855750 Completed - Lymphoma Clinical Trials

A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Start date: September 3, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.

NCT ID: NCT01854918 Completed - Clinical trials for Hyperlipidemia and Mixed Dyslipidemia

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

OSLER-2
Start date: April 23, 2013
Phase: Phase 3
Study type: Interventional

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

NCT ID: NCT01854645 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.

NCT ID: NCT01854047 Completed - Asthma Clinical Trials

An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Start date: June 2013
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma Secondary Objective: To evaluate different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma, with regard to: - Safety and tolerability - Dupilumab systemic exposure and anti-drug antibodies

NCT ID: NCT01853852 Completed - Fabry Disease Clinical Trials

A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects

Start date: September 2011
Phase: Phase 1
Study type: Interventional

GR181413A/AT1001 (migalastat hydrochloride) is a low molecular weight iminosugar, an analog of the terminal galactose group that is cleaved from the substrate GL-3. This compound was researched and developed as a drug for treatment of Fabry disease. This study, MGM115806, will be the first administration of GR181413A/AT1001 to Japanese subjects to investigate the safety, tolerability and pharmacokinetics of single oral doses in healthy Japanese adult subjects. Approximately 12 subjects will receive three treatments of 50, 150 and 450 mg GR181413A/AT1001 under fasted conditions plus placebo in a dose ascending crossover design. Serial pharmacokinetic samples will be collected and safety assessments will be performed following each dose. The pharmacokinetics and dose proportionality of GR181413A/AT1001 after single oral doses of GR181413A/AT1001 at the dose levels of 50, 150 and 450 mg under fasted conditions will be assessed.