16 results
PRIMARY OBJECTIVES Part I - To evaluate the efficacy (as measured by PFS) of GDC-0941 340 mg +carboplatin * paclitaxel (Arm A) versus carboplatin * paclitaxel (Arm B) in all patients with squamous NSCLC -To evaluate the efficacy (as measured by PFS…
To investigate how quickly and to what extent diclofenac is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administrated by using a HP 5000 transdermal patch. Furthermore, the pharmacokinetics of HP-5000…
To assess safety, tolerability and pharmacokinetics of a single subcutaneous administration of HPV-NIRD1.
The primary objective is to evaluate the effect of a once-a-weekprophylaxis regimen with BAY 79-4980 on the protection from all bleeds compared to a three times-per-week prophylaxis regimen with rFVIII-FSWFI.
The primary objectives of this study is:* To determine the safety and tolerability of rhHNS via ascending doses administered via a surgically implanted intrathecal drug device (IDDD) once monthly for 6 months, in patientswith MPS IIIA.The secondary…
The objective of this study is to assess the efficacy and safety of adalimumab in combination with a topical treatment for the treatment of patients with moderate to severe chronic plaque psoriasis.
The primary objectives of this study are:• To determine whether ART-123, when administered to subjects with infection complicated by at least one organ dysfunction and coagulopathy, can reduce mortality.• To determine the safety of ART-123 in this…
Phase 1• To establish the RP2D regimen by evaluation of the safety and tolerability of intravenous (IV) administration of Lutetium (177Lu) rhPSMA-10.1 injection in subjects with mCRPC.Phase 2• To evaluate the efficacy of Lutetium (177Lu) rhPSMA-10.1…
To assess the safety and tolerability of escalating single IV doses of NI-0801.To determine the pharmacokinetics and pharmacodynamics parameters of escalating single IV doses of NI-0801.
The purpose of this study is to investigate how quickly and to what extent different doses of EUapproved Tysabri® are absorbed and eliminated from the body (this is called pharmacokinetics) and how the body responds to different doses of Tysabri (…
Main objectives: safety and efficacy of BAY94-9027 for prophylaxis and treatment of bleeding in PTP with hemophilia ASecondary objective: PK
1. To evaluate the safety and tolerability of ascending multiple oral doses of HTL18318 in healthy adult male and female subjects.2. To evaluate the pharmacokinetics of ascending multiple oral doses of HTL18318 in healthy adult male and female…
The co-primary objectives of this study are: * To evaluate the efficacy of as measured by investigator-assessed PFS according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). * To evaluate the efficacy of atezolizumab as…
To assess which treatment leads to the best patient outcome on the short term (1 year) and the long term (5 years)
The purpose of this study is to evaluate the safety and efficacy of two doses of the study drug CT1812 per day for six months in subjects with mild to moderate Alzheimer's disease. CT1812 will be compared with a placebo. A placebo is a product…
To assess whether ADRB2 genotype-guided asthma treatment in children with persistend athma symptoms despite ICS treatment leads to better asthma control compared to non-genotype-guided asthma treatment.