24 results
Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…
To demonstrate the efficacy of ponatinib administered at 2 starting doses (30 and 15 mg QD) compared to nilotinib administered at 400 mg BID in patients with CP-CML who are resistant to imatinib, as measured by MMR by 12 months
Primary Objective:To determine the efficacy of ponatinib in patients with CML in CP, AP or BP or with Ph+ ALL who either:are resistant or intolerant to either dasatinib or nilotinib,Or:have the T315I mutation.Secondary Objectives:* To further…
Primary study aim:To determine the efficacy, in terms of the meadian progression-free survival, in patients with recurrent or metastatic endometrial cancer (including carcinosarcoma of the endometrium) receiving treatment with durvalumab and…
Primary: To determine whether the outcome of the RAD51 assay (HR proficient or HR deficient) correlates with objective response rate (RR) of olaparib, in patients with recurrent high grade epithelial ovarian cancer.Secondary:• Compare the…
The purpose of this study is to evaluate the efficacy and safety of LCZ696 compared to ramipril, in reducing the occurrence of cardiovascular (CV) death, heart failure (HF) hospitalization and outpatient HF (time-to-first event analysis) in post-AMI…
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…
To compare the antiproteinuric effects of sacubitril/valsartan (ARNI) and valsartan (ARB).
The primary objectives of this study are:- To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT proBNP from baseline after 12 weeks of treatment in patients with HFpEF.- To demonstrate that LCZ696…
This research study is designed to check whether olaparib is also effective in treating ovarian cancer which does not have a germline deleterious BRCA mutation, and whether olaparib causes any side effects.A tablet formulation of olaparib is being…
Primary:- To elucidate the change in physical activity as assessed by the distance walked in meters during the 6-minute walk test between baseline and 12weeks of study drug treatment in sacubitril/valsartan vs. enalapril patients.- To assess changes…
The primary objective:To compare LCZ696 to valsartan in reducing the rate of the composite endpoint of cardiovascular death andtotal (first and recurrent) heart failure (HF) hospitalizations, in HF patients (NYHA Class II-IV) with preserved EF (LVEF…
Olaparib + AZD1775 - this treatment arm was closed.Study objectives are defined for the following patient populations:* *Breast cancer susceptible gene mutation (BRCAm)* = patients from stratum A· *Homologous Recombination Repair gene mutation (HRRm…
To evaluate the effects of LCZ696 compared to valsartan on cognitive function over 3 years in patients with HFpEF as assessed by the CogState cognitive assessment battery.
The purpose of the study is to determine whether treatment with alpelisib in combination with olaparib can delay the time to cancer progression compared to standard-of-care chemotherapy in participants with your type of ovarian cancer known as…
Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
The primary objective of this study is to assess the safety and tolerability of sacubitril/valsartan compared with standard of care used for treating BP in patients that have been implanted with the HM3 LVAD.
The current trial aims to asses the safety of this combination in a phase I trial with olaparib dose escalation during two cycles of 177Lu-DOTATATE in salvage setting in patients with advanced GEP NET, progressive after initial PRRT.
This study is evaluating the preliminary efficacy of UV1-olaparib-durvalumab combination against both olaparib as monotherapy and olaparib-durvalumab combination in maintenance after platinum combination therapy for BRCAwt patients with relapsed…
Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.Secondary objectives1. To determine whether boosting reduces the inter- and intrapatient PK…