25 results
To demonstrate that crizotinib (Arm A) is superior to first-line chemotherapy, pemetrexed/cisplatin or pemetrexed/carboplatin (Arm B), in prolonging PFS in patients with advanced non-squamous NSCLC whose tumors harbor a translocation or inversion…
Primary objective: • To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD.Secondary objectives:• To assess the safety and tolerability of 2 different dosing…
Two key questions remain to be answered to further elucidate the mechanism of action: 1) is the effect on glucose metabolism dose dependent in Type 2 diabetes patients? and 2) Does UAG decrease glucose concentrations during an oral glucose loadThis…
Primary objectives:*To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of EPZ-5676 when administered as a 21-day or 28 day CIV infusion to patients with refractory hematologic malignancies.*To assess the safety and…
One of the he questions that remains to be answered to further elucidate the mechanism of action is whether ot not UAG improves insulin sensitivity during a euglycemis-hyperinsulinemic clampThis study aims to clarify the effects of the continuous…
Primary objectiveTo identify specific genes in the NO pathway that are turned on or off by inactivity. The results will disclose key-genes in the NO pathway relevant for vascular adaptations. Secondary objectiveTo correlate functional vascular…
To establish the safety and tolerablity of multiple doses of hLF1-11 given once daily for 10 days.
The primary objective is to assess the effects on amyloid plaque burden of administration of VX-745 for 12-weeks, as assessed by Dynamic 11C-PiB (Carbon-11 labeled Pittsburgh Compound B) PET Amyloid Scanning in patients with Mild Cogntitive…
The objectives of this study are to:- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 21 days per dosing cycle.- Evaluate the pharmacokinetics of gemcitabine and 2', 2'-difluorodeoxyuridine (dFdU, a…
Primary objective:Evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of multiple doses of intravenous (IV) ATYR1940 in adults 18 to 65 years of age, inclusive, with FSHDSecondary objective:Explore pharmacodynamic (PD)…
Study BP29541 is a first in-human, open-label, multicenter, dose-escalation Phase I clinical study of single-agent RO6958688. The study will be conducted in two parts. Part I of the study is single ascending dose in single patient cohorts to…
The objectives of this study are to:• Evaluate the safety, tolerability, and immunogenicity of long-term treatment with intravenous (IV) ATYR1940 in adult patients with facioscapulohumeral muscular dystrophy (FSHD) previously enrolled in clinical…
The objectives of the study are to: -To evaluate the safety and tolerability of MOTREM in patients with septic shock. -To evaluate the effects of MOTREM exposure over up to 5 days in patients with septic shock -To evaluate the PK/PD and dose/PD…
- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 7 days per dosing cycle - Evaluate the pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine (dFdU, a gemcitabine-related metabolite) exposure in…
Primary Objective*To assess the safety and tolerability of Patidegib Topical Gel, 2% inpatients who have completed PellePharm Study Pelle-926-201 or Pelle-926-301Secondary Objectives*To assess the efficacy of Patidegib Topical Gel, 2% in patients…
Primary Objective:- Efficacy of ARGX-113 as assessed by the percentage of "Myasthenia Gravis Activities of Daily Living (MG-ADL) responders" in the acetylcholine receptor (AChR)- antibody (Ab) seropositive population.Secondary Objectives:1…
The purpose of this study is to evaluate the effects of the addition of daratumumab to pomalidomide and dexamethasone in subjects with relapsed or refractory MM.1. Primary objectiveThe primary objective of this study is to compare PFS between…
Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To determine main change in ISM-SAF TSS from baseline to C7D1, compared to placebo. Part 3 • To assess the long-term…
From protocol amendment 3 27JUn2022, Clinical Study Protocol Synopsis, page 1Primary Objective• To demonstrate superiority of fianlimab 1600 mg + cemiplimab and/or fianlimab 400 mg+ cemiplimab compared to pembrolizumab, as measured by progression-…
Diabetic Macular Ischemia (DMI) is a complication of diabetic retinopathy (DR) and can lead to vision loss. Currently, there are no approved or effective treatments to prevent either onset or progression of DMI in DR patients.As a transition from…