A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE) A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-ne...

• Country France
• organs Sein
• Specialty Thérapies Ciblées, Hormonothérapie

Randomizovaná, multicentrická, dvojitě slepá ověřovací studie k posouzení účinku opakovaných infúzí přípravku AIN457 (10mg/kg) oproti placebu na aktivitu onemocnění měřenou MRI scany po dobu 24. týdnů u pacientů s recidivující-remitující roztroušenou sklerózou To determine the effect of AIN457 (10 mg/kg i.v.) administered week 0, 2, 4, 8, 12, 16 and 20 compared to placebo on the number of combined unique active lesions (CUAL) observed on brain MRI scans per...

• Country None
• organs None
• Specialty None

A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of Fluad® or Agrippal® in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months To explore the cell mediated immune (CMI) responses to two 0.25 mL IM injections of Fluad or to two 0.25 mL IM injections of Agrippal as determined by the quality and quantity of the antigen-specific ...

• Country None
• organs None
• Specialty None

A phase Ib/IIa, trial of LBH589 in combination with trastuzumab in adult female patients with HER2 positive metastatic breast cancer whose disease has progressed during or following therapy with trastuzumab • During dose escalation, to determine the MTD of LBH589 that can be combined with trastuzumab, in patients with HER2-positive MBC whose disease has progressed on or after trastuzumab: Arm 1 - Determi...

• Country None
• organs None
• Specialty None

A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303 To evaluate the safety profile of tobramycin inhalation powder after modifications in the manufacturing process (TIPnew) for the treatment of infections with P.aeruginosa in subjects suffering from cy...

• Country None
• organs None
• Specialty None

12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic after 3 months), vs. myfortic plus tacrolimus in de novo renal transplant recipients The primary objective of the study is to demonstrate that in de novo renal transplant patients, at least one of the AEB071 treatment regimens is not inferior to the control treatment (myfortic® + tacr...

• Country None
• organs None
• Specialty None

Étude CLDK378X2103 ; étude de phase 1, en escalade de dose, évaluant la tolérance et l’efficacité du ceritinib (LDK378), un inhibiteur de ALK, chez des enfants ayant un cancer présentant une altération génétique d’ALK. [Informations issues du site clinicaltrials.gov et traduites par l'INCa] [essai clos aux inclusions] CLDK378X2103 - A phase I, open-label, dose escalation study of LDK378 in pediatric patients with malignancies that have a genetic alteration in anaplastic lymphoma kinase (ALK)

• Country France
• organs Tout Cancer
• Specialty Thérapies Ciblées

A study evaluating if the addition of MCS110 increases the efficacy of chemotherapy in women with disseminated breast cancer that is not dependent on hormones To assess the anti-tumor activity of MCS110 combined with carboplatin/gemcitabine (carbo/gem) compared to carbo/gem alone.

• Country None
• organs None
• Specialty None

Phase Ib/II trial of BEZ235 with paclitaxel in patients with HER2 negative, locally advanced or metastatic breast cancer Estudio fase Ib de BEZ235 más paclitaxel, en pacientes con cáncer de mama metastásico o localmente avanzado inoperable, HER2 negativo Phase Ib: to determine the MTD of BEZ235 in combination with paclitaxel Phase II: to estimate the treatment effect of BEZ235/paclitaxel combination therapy versus paclitaxel alone Fase Ib: Det...

• Country None
• organs None
• Specialty None

A multi-center, randomized, double-blind, placebo- controlled, two-period cross-over study to assess the effect of 50µg inhaled NVA237 on exercise endurance in patients with moderate to severe COPD To determine the effect of 50 µg NVA237 compared with matching placebo inhaled once daily on exercise tolerance as measured by exercise endurance time during a sub-maximal constant-load cycle ergometr...

• Country None
• organs None
• Specialty None