19 results
To demonstrate that macitentan improves exercise capacity in comparison with placebo in subjects with Eisenmenger Syndrome (ES).
To assess the long-term safety and tolerability of macitentan in patients with symptomatic pulmonary arterial hypertension (PAH).
Primary ObjectivesPhase 1 portion:• to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2/day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2/day on Days 1-5 of a 28 day cycle. • to determine…
Primary objective* To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) at rest in comparison with placebo in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).Secondary objectives* To…
The primary objective of the study is to assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment…
Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).
The primary objective of this study is to assess the feasibility (safety and efficacy) of addition of 10-day decitabine to the standard Seattle non-myeloablative conditioning regimen (3 days fludarabine 30 mg/m2 + 2 Gray TBI) prior to allogeneic HCT…
Primary objectives:• To assess early mortality risk (first 30 days after start of induction therapy) of treatment with decitabine-cytarabine in elderly patients with AML or high risk myelodysplastic syndrome (IPSS >=1.5) with a high risk of…
Primary objectiveTo compare the effect on pulmonary vascular resistance (PVR) of an initial triple oral regimen (macitentan, tadalafil, selexipag) versus an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-…
The primary objective of this study is to compare, in a randomized phase III trial, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (*3+7*) on OS in older AML patients.
The primary objective of the study is to evaluate the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic PAH.Secondary objectivesTo evaluate the safety and tolerability of macitentan in patients with…
To assess and compare efficacy (complete response [CR] rate and overall survival [OS]) between SGI-110 and TC in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.
Primary objective:Part I- To asses the feasibility of addition of post-transplant panobinostat combined with decitabine to a regimen of T-cell replete RIC alloHSCT in patients with very poor risk AML/RAEB, and select the dose level for the phase II…
Primary* To compare the composite complete remission (CRc) rate (morphologic complete remission [CR] and morphologic CR with incomplete hematologic recovery [CRi]) between treatment arms * To compare overall survival (OS) between treatment…
To determine whether VSA treatment with the novel ERA macitentan reduces the frequency and severity of anginal complaints among patients with clinically defined VSA. To determine side effects related to treatment with macitentan in patients with VSA…
Primary objectives:- To assess in a randomized comparison the effect of midostaurin added to 10-day decitabine treatment on the cumulative CR/CRi rate during 3 cycles.Secondary objectives:- To assess the safety and tolerability of midostaurin added…
Primary: To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with decitabine or azacitidine in relapsed/refractory AML patients, de novo AML patients not candidates for standard induction therapy, or high risk or…
Primary objectives1. To assess in a randomized comparison the effect of Ibrutinib added to 10-day decitabine treatment on the cumulative CR/CRi rate after 3 cycles.Secondary objectives1. To assess the safety and tolerability of Ibrutinib added to 10…
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary…