16 results
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.
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…
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 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…
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 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…
- 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…
As of 15 June 2018, only patients from the ECH study (Study TV48125 CNS 30056) will enroll in this study for active treatment. As of 15 June 2018, all CCH patients included in this study have been asked to discontinue treatment, and are encouraged…
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…
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…
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…
Main objective:- To evaluate the long-term safety and tolerability of ARGX-113 in acetylcholine receptor antibody (AChR-Ab) seropositive patients.Secondary objective:- To evaluate the long-term safety and tolerability of ARGX-113 in the overall…
Primary: • The primary objective is to determine adjudicated ORR (CR/CR with partial recovery of peripheral blood counts [CRh] + PR + CI) based on modified IWG-MRT-ECNM consensus response criteria in patients with AdvSM treated with avapritinib and…