55 results
The primary purpose of the study is to determine the efficacy of AZD2281 compared to placebo in serous ovariancancer platinum sensitive patients and in a defined HRD subset.
Primary objectiveTo evaluate and compare the single-dose pharmacokinetic of turoctocog alfa pegol from the pivotal process with turoctocog alfa pegol from the commercial process, each given as intravenous administrations of 50 U/kg to patients with…
Primary objective:- To assess the safety of concizumab given as multiple s.c. doses to subjects with haemophilia ASecondary objectives:- To assess pharmacokinetics of concizumab in subjects with haemophilia A after multiple s.c. doses- To assess…
To assess the efficacy, measured as progression free survival, and safety of Selumetinib in combination with docetaxel, compared to docetaxel alone, in patients receiving second line treatment for KRAS mutation negative locally advanced or…
Primary objective:To compare the effects of AZD7624 vs. placebo on the time to first event of moderate or severe COPD exacerbation or early drop-out related to worsening of COPD symptoms (composite endpoint) in patients with COPD on maintenance…
This study is designed to demonstrate non inferiority of 150 *g o.d. of indacaterol versus tiotropium 18 *g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment.
Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…
During the last several years, substantial progress has been made regarding the biologic characterization of the acute leukemias. The traditional understanding that myeloid leukemic cells are developmentally similar to their normal hematopoietic…
To determine the efficacy of olaparib versus placebo on progression free survival (PFS).
The primary objective of this study is to evaluate the effect of multiple oral doses of vemurafenib (960 mg BID) on the PK of a single oral dose of acenocoumarol (4 mg).The secondary objective of this study is to assess the safety and tolerability…
The primary objective is to confirm that bronchodilator monotherapy (tiotropium) plus behavioural modification, bronchodilator combination therapy (tiotropium + olodaterol FDC) plus behavioural modification, and bronchodilator combination therapy (…
The main purpose of the study is to evaluate the safety and tolerability (any toxicities and side effects) of SAR405838 and Pimasertib and that includes identifying the maximum safe and tolerable dose of the study drugs. Also to assess the anti-…
To evaluate the efficacy of pasireotide LAR and everolimus alone or in combination in progressive patients with a well differentiated neuroendocrine tumor of the lung or thymus.
Primary objectives* To determine the Overall Response Rate (ORR) in patients with (FGFR3MUT) advanced urothelial carcinoma treated with TKI258* To determine the Overall Response Rate (ORR) in patients with (FGFR3WT) advanced urothelial carcinoma…
OBJECTIVES AND HYPOTHESISPrimary ObjectivesThe primary objectives are to determine- the effect of steady-state telaprevir 750 mg every 8 hours (q8h) on the multiple dose pharmacokinetics ofphenytoin 200 mg every 12 hours (q12h) in healthy subjects,…
There is no formal research hypothesis for this study. The purpose is to evaluate the effects of dapagliflozin on kidney function (GFR) and the changes from baseline in the ambulatory Blood Pressure. The effects of dapagliflozin on red cell mass and…
The purpose of this study is to evaluate the effects of QVA149 300/50, a fixed dose combination of QAB149 300µg and NVA237 50µg, versus placebo and two doses of QAB149 300µg and 600µg, in terms of lung function in patients with moderate to severe…
The study is designed to compare the 24-h spirometry profile of two doses of indacaterol (150o.d. and 300 *g o.d.) with that of placebo (o.d.) and with tiotropium (18 *g o.d.) as an activecontrol in patients with COPD.
The purpose of the study is to collect long-term data of safety, tolerability, and efficacy to support the submission of marketing authorisation of one-month dosing regimen of degarelix for treatment of prostate cancer.Primary Objective:•To evaluate…
The objectives of this study are as follows:Primary Efficacy Objective:• To assess the effect of PG-760564 on the proportion of patients meeting the American College of Rheumatology 20 response criteria (ACR 20) at 12 weeks;11Secondary Efficacy…