LBCTR2019070266 | CLCZ696B2319E1 | CLCZ696B2319E1 Open Label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With Heart Failure (HF). | A multicenter study to evaluate long-term safety and tolerability of open label sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed study CLCZ696B2319 | Interventional | Complete | 17/07/2019 |
LBCTR2019121369 | CLDK378A2112 | ASCEND 8-Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC) | A Multi-center, Randomized Open Label Study to Assess the Systemic Exposure, Effiacy, and Safety of 450 mg Ceritinib Taken With a Low-fat Meal and 600 mg Ceritinib Taken With a Low-fat Meal as Compared With That of 750 mg Ceritinib Taken in the Fasted State in Adult Patients With ALK Rearranged (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC) | Interventional | Complete | 27/12/2019 |
LBCTR2019121370 | CLDK378A2301 | ASCEND 4:LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib | A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib | Interventional | Complete | 27/12/2019 |
LBCTR2019121371 | CLDK378A2303 | ASCEND 5: LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib | A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib | Interventional | Complete | 27/12/2019 |
LBCTR2019010182 | CLDK378A2X01B | CLDK378A2X01B Roll over study in patients with ALK postive malignancies | An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib | Interventional | Complete | 09/01/2019 |
LBCTR2019050229 | CLEE011A2301 | Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) | A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease | Interventional | Complete | 03/05/2019 |
LBCTR2019010184 | CLEE011A2404 | COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease | COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease | Interventional | Complete | 11/01/2019 |
LBCTR2022095114 | CLEE011A2412B | Roll-over Study to Allow Continued Access to Ribociclib | A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study | Interventional | Complete | 17/08/2022 |
LBCTR2019060241 | CLEE011A3201C | Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer ( Right Choice) | A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer | Interventional | Complete | 03/06/2019 |
LBCTR2019020194 | CLEE011E2301 | A phase III randomized , double blind, placebo controlled study of LEE011or placebo in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI)and goserelin for the treatment of premenopausal women with hormone receptor positive, HER 2 negative, advanced breast cancer. ( MONALEESA 7) | A phase III randomized , double blind, placebo controlled study of LEE011or placebo in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI)and goserelin for the treatment of premenopausal women with hormone receptor positive, HER 2 negative, advanced breast cancer. | Interventional | Complete | 15/02/2019 |