Search results for "phase i"

Ramucirumab in patients with previously treated advanced hepatocellular carcinoma: Impact of liver disease aetiology.

2021

BACKGROUND & AIMS Hepatocellular carcinoma (HCC) is a common complication of chronic liver disease with diverse underlying aetiologies. REACH/REACH-2 were global phase III studies investigating ramucirumab in advanced HCC (aHCC) following sorafenib treatment. We performed an exploratory analysis of outcomes by liver disease aetiology and baseline serum viral load. METHODS Meta-analysis was conducted in patients with aHCC and alpha-fetoprotein (AFP) ≥400 ng/mL (N = 542) from REACH/REACH-2 trials. Individual patient-level data were pooled with results reported by aetiology subgroup (hepatitis B [HBV] or C [HCV] and Other). Pre-treatment serum HBV DNA and HCV RNA were quantified using Roche CO…

Treatment of multiple sclerosis with interferon beta in clinical practice: 2-year follow-up data from the South Italy Mobile MRI Project.

2006

This follow-up study assessed the 2-year clinical and magnetic resonance imaging (MRI) outcomes of patients with multiple sclerosis (MS) originally enrolled in an MRI study conducted at eight centres in south Italy (the South Italy Mobile MRI Project). Of the 597 MS patients recruited at baseline, 391 returned for the follow-up study. Of these, 363 provided 2-year clinical and MRI follow-up data, and 215 were still undergoing treatment with one of four interferon beta regimens: Avonex, 30 mcg intramuscularly once weekly; Betaferon, 250 mcg subcutaneously (sc) every other day; Rebif 22 mcg sc three times weekly (tiw; Rebif 22); or Rebif 44 mcg sc tiw (Rebif 44). Over the 2-year follow-up per…

Esophageal cancer: Clinical Practice Guidelines for diagnosis, treatment and follow-up

2010

Esophageal cancer: Clinical Practice Guidelines for diagnosis, treatment and follow-up M. Stahl, W. Budach, H.-J. Meyer & A. Cervantes On behalf of the ESMO Guidelines Working Group* Department of Medical Oncology and Centre of Palliative Care, Kliniken Essen-Mitte, Essen; Department of Radiation Oncology, University of Dusseldorf, Dusseldorf; Department of Surgery, Stadt Klinikum Solingen, Germany; Department of Hematology and Medical Oncology, INCLIVA, University of Valencia, Valencia, Spain

Clinical Efficacy of Laquinimod for the Treatment of Multiple Sclerosis; Pooled Analyses from the ALLEGRO and BRAVO Phase III Trials (S01.007)

2012

Objective: The current report provides detail on pooled analyses assessing the effect of laquinimod on relapse, disability, and brain atrophy measures from the recently completed phase III trials ALLEGRO and BRAVO. Background Laquinimod is an oral, CNS acting immunomodulator in development for the treatment of multiple sclerosis. Its impact on disability progression and brain atrophy, two indices of longterm outcome for patients with multiple sclerosis (MS) are being studied in its phase III trials. Design/Methods: MS patients (N=2437) were randomized to laquinimod (n=984) or placebo (n = 1006). In both trials, patients underwent neurological examinations including the Expanded Disability S…

Results of a Phase I-II Pilot Study with Intravescical Gemcitabine in Superficial Bladder Cancer (Ta-T1)

2005

To study the ablative activity of intravescical gemcitabine against superficial transitional cell carcinoma of the bladder at different doses and concentrations. Methods Twenty-seven patients were treated with intravescical gemcitabine after transurethral resection, during which one to three papillary marker lesions were left unresected. Starting 14 days after transurethral resection, six gemcitabine instillations were given at weekly intervals. Gemcitabine, diluted in 50 mL of saline solution and maintained for 2 hr, was given at a dose of 500, 1000 and 2000 mg in groups of nine patients each. A complete response (CR) was defined as negative cutologycystoscopy and biopsy findings. Results…

Safety and tolerability of local treatment with iloprost, a prostacyclin analogue, in patients with Peyronie's disease: a phase I study

2011

Recent clinical evidence on metronomic dosing in controlled clinical trials: a systematic literature review.

2020

Introduction: Metronomic dosing is used to give continuous chemotherapy at low doses. The low doses have minimal side effects and may enable cancer treatment to be remodeled toward the management o...

Minimally Invasive Approaches in Locally Advanced Cervical Cancer Patients Undergoing Radical Surgery After Chemoradiotherapy: A Propensity Score Ana…

2020

Abstract Purpose Chemoradiation (CT/RT) followed by radical surgery (RS) may play a role in locally advanced cervical cancer (LACC) patients with suboptimal response to CT/RT or in low-income countries with limited access to radiotherapy. Our aim is to evaluate oncological and surgical outcomes of minimally invasive radical surgery (MI-RS) compared with open radical surgery (O-RS). Patients and Methods Data for stage IB2–IVA cervical cancer patients managed by CT/RT and RS were retrospectively analyzed. Results Beginning with 686 patients, propensity score matching resulted in 462 cases (231 per group), balanced for FIGO stage, lymph node status, histotype, tumor grade, and clinical respons…

Rationale and design of the EMBRACE STEMI Study: A phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability …

2012

Background Although significant efforts have been made to improve ST-segment elevation myocardial infarction (STEMI) outcomes by reducing symptom-onset-to-reperfusion times, strategies to decrease the clinical impact of ischemic reperfusion injury have demonstrated limited success. Bendavia, an intravenously administered mitochondrial targeting peptide, has been shown to reduce myocardial infarct size and attenuate coronary no-reflow in experimental modelswhen given before reperfusion. Design The EMBRACE STEMI study is a phase 2a, randomized, double-blind, placebo-controlled trial enrolling 300 patients with a first-time anterior STEMI and an occluded proximal or mid–left anterior descendin…

Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in h…

2021

A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults ≥65 y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60–64 y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged ≥60 y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged ≥60 y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180 d after vaccinat…