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DAY101-001/PNOC026/FIREFLY-1: A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with RAF-Altered Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors
DAY101 is an oral, selective, small-molecule, Type II pan-RAF kinase inhibitor that is being developed by DOT Therapeutics-1 Inc. (Day One, the Sponsor) for the ... -
Site for AALL1821: A Phase 2 Study of Blinatumomab (NSC# 765986 IND# 125462) in Combination with Nivolumab (NSC# 748726 IND# 125462) a Checkpoint Inhibitor of PD-1 in B-ALL Patients Aged >/=1 to
Site for This phase II trial investigates how well nivolumab when given together with blinatumomab work compared to blinatumomab alone in treating patients with CD19 ... -
A randomized phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for Stage I HER2-positive breast cancer (ATEMPT 2.0)
This is a randomized phase II adjuvant study for women and men with Stage I HER2-positive invasive breast cancer. At least 500 eligible patients will ... -
Interventional randomized double-blind parallel-group placebo-controlled multi-centre study to assess the efficacy safety and tolerability of Lu AF82422 in patients with Multiple System Atrophy
This is a phase II, interventional, randomized, double-blind, parallel-group, placebocontrolled, multi-centre study of the efficacy (slowing disease progression), safety, and tolerability of Lu AF82422 in ... -
A Follow-Up Open-Label Research Evaluation of Sustained Treatment with Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
This is an open-label study of CK-3773274 in patients with HCM. The treatment duration is anticipated to be multiple years, concluding when marketing authorization is ... -
CBYL719F12201: EPIK-P2 Phase II double-blind study w/ upfront 16-week randomized placebo-controlled period to assess efficacy safety & pharmacokinetics of alpelisib (BYL719) in pediatric & adult patients w/ PIK3CA-related overgrowth spectrum (PROS)
This study will be the first prospective study of alpelisib in participants with PROS. Local overgrowth or hemihypertrophy, mostly progressive, is the most frequently observed ... -
Biomarker and Edema Attenuation in IntraCerebral hemorrhage (BEACH)
This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). This study ... -
A Phase II Study of Ribociclib And Endocrine Treatment of Physician s Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Primary Objective: To estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant), in patients with Hormone Receptor ... -
Randomized placebo controlled trial to determine the biological signature of cannabidiol as a treatment for social anxiety disorder
The goals of these two phased studies (“R61” followed by “R33”) are to establish a biological signature of CBD’s putative therapeutic effects in SAD ... -
A Pilot Phase II Open-Label Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder
This is an open-label, single arm clinical trial preliminarily testing the antidepressant effects of empagliflozin in patients with major depressive disorder (MDD), and assessing its ...