Sentences with phrase «open label phase»

Thirty six children aged 5 — 17 years with an autism spectrum disorder (Autism Diagnostic Interview - Revised plus clinical judgement) enrolled in the open label phase, 24 children who responded to risperidone were randomised.

FORWARD1: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women with Folate Receptor Alpha - Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

The randomized, open label Phase 2 trial is ongoing and evaluating CMB305 and atezolizumab in patients with locally advanced, relapsed, or metastatic synovial sarcoma or myxoid / round - cell liposarcoma, two types of sarcoma that tend to express NY - ESO - 1 broadly.

Not exact matches

Presentations will highlight the short and long - term effects of Ingrezza on tardive dyskinesia symptoms by body region, long term safety and efficacy data from the KINECT 4 phase 3 open label study and also from RE-KINECT (real - world screening study of patients with possible TD).

This open label, multicentre, phase 1B trial investigated the safety and efficacy of omaveloxolone in combination with the checkpoint inhibitors ipilimumab or nivolumab.

The Phase I clinical trial of OMP - 54F28 (FZD8 - Fc) is an open - label dose escalation study in patients with advanced solid tumors for which there was no remaining standard curative therapy.

International researchers prospectively analyzed and compared tumor and matched plasma DNA for EGFR mutations from 1060 patients that were screened as part of a phase IV, open - label, single - arm, first - line gefitinib in EGFR mutation positive Caucasian patients.

The study found that patients who received T - sol during the open - label phase had improved symptoms regardless of whether they had received placebo during the blinded phase.

A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN (rAd - IFN / Syn3) Administered Intravesically to Patients with High Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer

A Phase 1, First - in - Man, Multicenter, Open - Label, Two Part Dose - Escalation and Cohort Expansion Study of Single - Agent GBR 1342 in Subjects with Previously Treated Multiple Myeloma

A Phase 3 Open - label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation

A Phase 3 Open - Label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3 - ITD Positive Acute Myeloid Leukemia (AML) Refractory To or Relapsed After First - line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

14255: STAT3 Signaling During Chemo - Radiation for Squamous Cell Carcinoma of the Head and Neck 14340: A Phase II, Randomized, Open - Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination with Tremelimumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) 14258: Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

A Phase 1/2, Open - Label, Dose - Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies

My Pathway: An Open - Label Phase IIA Study Evaluating Trastuzumab / Pertuzumab, Erlotinib, Vemurafenib / Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents

A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza) versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration - Resistant Prostate Cancer who have Failed Prior Treatment with a New Hormonal Agent and have Homologous Recombination Repair Gene Mutations.

A Phase 1/2, Multicenter, Open - label Study of FT - 2102 as a Single Agent and in Combination with Azacitidine or Cytarabine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome with an IDH1 Mutation

A Phase 1b / 2 Open - Label Study to Evaluate Safety, Clinical Activity, Pharmacokinetics and Pharmacodynamics of Avelumab (MSB0010718C) in Combination with Other Cancer Immunotherapies in Patients with Advanced Malignancies

A Phase 1, Multicenter, Open - Label, Safety Study of AG - 120 or AG - 221 in Combination with Induction Therapy and Consolidation Therapy in Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 and / or IDH2 Mutation

Randomized, Open - Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum - Doublet Chemotherapy versus Platinum - Doublet Chemotherapy in Early Stage NSCLC

ISIS - SMNRx is also being evaluated in an open - label, multiple - dose, dose - escalation Phase 2 study in infants with Type I SMA.

A Phase 1/2 Open - label Study of the Safety, Tolerability and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Compound KPT - 8602 in Patients with Relapsed / Refractory Cancer Indications

A Phase 3, Randomized, Open - Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed / Refractory Diffuse Large B Cell Lymphoma (ZUMA - 7)

A Phase III Randomized Open - Label Multi-Center Study of Ruxolitinib vs. Best Available Therapy in Patients with Corticosteroid - Refractory Chronic Graft vs Host Disease after Allogenic Stem Cell Transplantation (REACH 3)

An Open - Label, Randomized, Phase 2 Dose - Finding Study of Pacritinib in Patients with Thrombocytopenia and Primary Myelofibrosis, Post - Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocytopenia Myelofibrosis Previously Treated with Ruxolitinib

A Multicenter, Randomized, Open - label, 3 - Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan / Cetuximab or Infusional 5 - Fluorouracil (5 - FU) / Folinic Acid (FA) / Irinotecan (FOLFIRI) / Cetuximab with a Safety Lead - in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E - mutant Metastatic Colorectal Cancer

An Open Label, Phase II Study of Neratinib in Patients with Solid Tumors with Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

A Phase I / II, Open - label, Multi-center Study of the Safety and Efficacy of IMCgp100 using the Intra-patient Escalation Dosing Regimen in Patients with Advanced Uveal Melanoma

A Phase Ib, Open - Label Study of the Safety and Tolerability of Atezolizumab in Combination with Radium - 223 Dichloride in Patients with Castrate - Resistant Prostate Cancer who have Progressed Following Treatment with an Androgen Pathway Inhibitor

CARLSBAD, Calif., June 11, 2015 — Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) today provided an update on its ongoing open - label Phase 2 clinical study of ISIS - SMNRx in infants with Type I spinal muscular atrophy (SMA).

A Phase 3, Multicenter, Randomized, Open - Label Study of Guadecitabine (SGI - 110) versus Treatment Choice in Adults with Previously Treated Acute Myeloid Leukemia

An Open - Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B - 6527 in Subjects with Advanced Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

An Open - Label, Multicenter Phase I Study to Characterize the Safety, Tolerability, Preliminary Anti-Tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY 1251152 in Patients with Advanced Hematological Malignancies

A Multi-arm, Phase Ib, Open - Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Combination with Ascending Doses of Novel Therapeutics in Patients with EGFRm + Advanced NSCLC who have progressed following therapy with an EGFR TKI (TATTON)

An Open Label, Multicenter, Single Arm Phase II Pilot Study to Evaluate the Efficacy and Tolerability of the Novel mTOR Inhibitor, MLN0128 (TAK - 228), in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract whose Tumors Harbor a TSC1 and / or a TSC2 Mutation

A Phase 2b Open - Label Extension Study to Evaluate the Long - term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001 - 201 (PRONTO)

Bornhäuser M, Kienast J, Trenschel R, et al Reduced - intensity conditioning versus standard conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission: a prospective, open - label randomised phase 3 trial.

The Phase 1 open - label, multicenter, dose escalation study of mRNA - 2416 is designed to determine the safety and tolerability of escalating iTu doses of mRNA - 2416 in patients with relapsed / refractory solid tumor malignancies or lymphoma, and define the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) and schedule for iTu injections of mRNA - 2416.

The COLUMBUS trial was a randomized, open - label, phase III trial that took place in 28 countries.

AST - VAC1 was previously tested in a multi-center, open - label, Phase 2 clinical trial in patients with intermediate and high risk AML.

The clinical trial is open labelled for the phase Ia arm conducted in Tübingen, Germany and double blinded for the phase Ib conducted at the Institut de Recherche Clinique du Bénin, Benin.

Phase II, open - label, single - arm trial of imatinib mesylate in patients with metastatic melanoma harboring c - Kit mutation or amplification.

Limitations of this study include that it was a longitudinal roll - over, re-dose, open - label study of 28 patients who received their fi rst dose in CS2 and then transferred to the second phase, CS12.

[iv] Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open - label, phase 3 trial.

A Phase 1b / 2 Open - label Dose Escalation Study of Entinostat in Combination With Pembrolizumab in Patients With Non-small Cell Lung Cancer With Expansion Cohorts in Patients With Non-small Cell Lung Cancer and Melanoma

U.S. Phase 1 Trial in SMA Type 2 (STRONG) The open - label, dose - comparison, multi-center Phase 1 trial — known as STRONG — is designed to evaluate the safety, optimal dosing, and proof of concept for efficacy of AVXS - 101 in two distinct age groups of patients with SMA Type 2, utilizing a one - time IT route of administration.

To combat the nation's third deadliest cancer, the phase 1b / 2 open - label study will explore the combination of standard chemotherapy and two immunotherapy agents: an anti-PD-1 checkpoint inhibitor and a novel antibody targeting CD40, a protein that when activated can drive the immune system to attack tumors.

A phase II multicenter, randomized, open - label trial of T - VEC [28] in patients with resectable stage IIIB, IIIC, or IV M1a melanoma testing that hypothesis is in the enrollment phase.

PPMD and Action Duchenne hosted a webinar update last week on the recent report that Summit has announced positive 24 - week interim results from the open - label Phase 2 proof of concept clinical trial, PhaseOut DMD.

An Open - Label Phase 2a Proof - of - Concept Study (February, 2012) in Lancet Neurology.