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NCT ID: NCT02281084 Completed - Clinical trials for Myelodysplastic Syndromes

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes

Start date: July 6, 2015
Phase: Phase 2
Study type: Interventional

Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason for removing the combination arm: Due to difficulties with dose-finding, the durvalumab plus CC-486 combination arm was closed to enrollment. Extension: An Extension Phase (EP) has been added to allow subjects who are currently receiving oral azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine until the subject meets the criteria for study discontinuation.

NCT ID: NCT02281019 Completed - Biliary Stricture Clinical Trials

SpyGlass AMEA Registry

Start date: November 15, 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.

NCT ID: NCT02280434 Completed - Autoimmune Diseases Clinical Trials

Phase 1 Study Accessing the Safety and Tolerability of CBP-307

Start date: November 2014
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-307 following oral single and multiple escalating dose administration in healthy subjects.

NCT ID: NCT02279862 Completed - Prostate Cancer Clinical Trials

Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive

Start date: December 2, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

NCT ID: NCT02279745 Completed - Clinical trials for Pulmonary Arterial Hypertension

Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension

Start date: July 8, 2015
Phase: Phase 2
Study type: Interventional

This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) who have completed Study APD811-003, or who were assigned to receive placebo and were discontinued due to clinical worsening.

NCT ID: NCT02279173 Completed - Clinical trials for Immune Thrombocytopenia

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)

Start date: December 10, 2014
Phase: Phase 3
Study type: Interventional

This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the absence of ITP rescue medications for the past 4 weeks.

NCT ID: NCT02279160 Completed - Clinical trials for Pulmonary Arterial Hypertension

Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

Start date: December 2014
Phase: Phase 2
Study type: Interventional

The study was conducted as a placebo-controlled, randomized, 22-week double-blind study which included a dose titration period. An additional transition period occurred for those patients who elected to enroll into the open-label extension study, APD811-007. A total of 61 patients with PAH were enrolled.

NCT ID: NCT02279095 Completed - Clinical trials for Fibrodysplasia Ossificans Progressiva

An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)

Start date: October 9, 2014
Phase: Phase 2
Study type: Interventional

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. In this study, the ability of different palovarotene dosing regimens to prevent the formation of new HO will be evaluated in adult and pediatric participants with FOP.

NCT ID: NCT02278133 Completed - Clinical trials for Metastatic Colorectal Cancer

Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions. The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.

NCT ID: NCT02278120 Completed - Clinical trials for Advanced Metastatic Breast Cancer

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

MONALEESA-7
Start date: November 20, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.