22 results
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)…
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…
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…
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, 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 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…
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…
This first-in-man study will investigate the safety and tolerability as well as establish a recommended dose of INCB081776 as a monotherapy (Part 1) and then in combination with INCMGA00012 (Part 2) in participants with advanced malignancies. During…
The purpose of this study will be to evaluate and compare the effectiveness of a multifocal SMR treatment on pain and stiffness compared to ECC in active recreational runners with self-reported Achilles tendon complaints.Research question: Is a 12-…
Primary Objective: The first objective of this study is to evaluate efficacy of adjuvant HAIP chemotherapy after repeat hepatectomy for recurrent CRLM in the Erasmus MC.Secondary Objective(s): The second objective is to determine treatment related…
Part I (dose-escalation): to evaluate the safety of SYD985 and to determine the Maximum Tolerated Dose and Recommended Phase 2 DosePart II (expanded cohorts): to evaluate the Objective tumour Response Rate
Primary Objective: The first objective of this study is to evaluate the safety and feasibility of adjuvant HAIP chemotherapy after resection of CLM in 2 centres in the Netherlands.Secondary Objective(s): The second objective is to determine whether…
- 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…
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…
The primary objective of this study is to evaluate the safety and tolerability and determine the MTD and RDE(s) of INCB123667 as monotherapy in participants with selected advanced or metastatic solid tumors.The secondary objective is to evaluate the…
The primary objective is to evaluate the safety, tolerability, and doselimiting toxicities, and determine the recommended dose for expansionof INCA00186 as monotherapy and of combination treatments of INCA00186 with retifanlimab and/or INCB106385 in…
The aim of the study is to demonstrate that HAIP chemotherapy is an effective treatment for unresectable intrahepatic cholangiocarcinomas.
Phase I Dose Escalation1.To determine the RP2D in terms of safety and tolerability for:•IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC•IT admin of HB-201 in patients with HPV 16+ confirmed cancers•IV admin of HB-202 in patients with HPV…
The primary objective is to compare the efficacy of surgery and adjuvant HAIP chemotherapy to surgery alone in patients with resectable colorectal liver metastases with a low clinical risk score (CRS 0-2 point). Secondary objectives are to compare…
Primary:To determine the efficacy of INCB000928 for the prevention of new HO in participants with FOP.Key Secondary:To further evaluate the efficacy of INCB000928 in the reduction of flares and improvement in flare-related symptoms.Secondary:- To…