Search results for "Open label"
showing 10 items of 28 documents
A randomized, open-label, two-arm phase II trial comparing the efficacy of sequential ipilimumab (ipi) versus best supportive care (BSC) following fi…
2016
4011Background: Pts with advanced gastric cancer have a poor prognosis with median overall survival (OS) of ~1 yr. Ipi is a monoclonal antibody that enhances T-cell activation and T-effector cell t...
Phase I multicenter, open-label study to establish the maximum tolerated dose (MTD) of trifluridine/tipiracil (TAS-102) and oxaliplatin combination i…
2018
816 Background: Preclinical evidence suggests improved efficacy when combining trifluridine/tipiracil with oxaliplatin compared to each monotherapy (Nukatsuka, 2015). The primary objective was to determine the MTD and the safety profile of the doublet among mCRC pts who have progressed after at least one prior line of treatment. Methods: Using a 3+3 design, eligible pts received escalating trifluridine/tipiracil doses from 25, 30 to 35 mg/m² bid, days 1–5 q14, together with a fixed dose of oxaliplatin 85 mg/m² (day 1). An intermediate cohort with a lower dose of oxaliplatin (65 mg/m²) plus 35 mg/m² of trifluridine/tipiracil was also tested. Results: Fifteen of 17 enrolled pts were evaluabl…
Pimasertib (PIM) versus dacarbazine (DTIC) in patients (pts) with cutaneous NRAS melanoma: a controlled, open-label phase II trial with crossover
2016
Preliminary Results of CitraVes™ Effects on Low Density Lipoprotein Cholesterol and Waist Circumference in Healthy Subjects after 12 Weeks: A Pilot O…
2021
Appropriate monitoring and control of modifiable risk factors, such as the level of low-density lipoprotein cholesterol (LDL-C) and other types of dyslipidemia, have an important role in the prevention of cardiovascular diseases (CVD). Recently, various nutraceuticals with lipid-lowering effects have gained attention. In addition to the plant-derived bioactive compounds, recent studies suggested that plant cells are able to release small lipoproteic structures named extracellular vesicles (EVs). The interaction between EVs and mammalian cells could lead to beneficial effects through anti-inflammatory and antioxidant activities. The present study aimed to assess the safety of the new patente…
Resistance to water and abrasion of a broad-spectrum sunscreen: a prospective, open-label study.
2015
Fumaric acid ester treatment in cutaneous lupus erythematosus (CLE): a prospective, open-label, phase II pilot study.
2016
Objective The aim of the study was to assess the efficacy and safety of fumaric acid esters (FAEs) in patients with cutaneous lupus erythematosus (CLE). Methods In this 24-week, prospective, open-label, phase II pilot study, 11 patients with CLE, refractory to topical corticosteroids, were included. The primary endpoint of the study was the evaluation of the efficacy of FAEs after 24 weeks of treatment as assessed by the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI). Results Compared to baseline, significant improvement in the mean total RCLASI activity score and the mean RCLASI activity score for skin lesions was observed in week 12 ( p = 0.002, p = 0.002, respectively) …
Outcome comparison of integrated psycho‐oncological care versus unstructured care—Results of a non‐randomised open‐label two‐arm trial
2019
Objective To compare patients' experiences with a systematic, integrated psycho-oncological care (IC) model to experiences with "care as usual" (CAU). Methods To improve patients' knowledge about psychosocial support options and to facilitate use, an IC model was developed by psycho-oncologists and a health insurance company and implemented in one German cancer care facility. Using a parallel, non-randomised design, these patients' experiences were compared to CAU patients. In 2015, both patient groups received questionnaires 6-12 months post-inpatient treatment. Main outcomes were awareness, use and opinion of psycho-oncological care (PC) and anxiety level (Generalized Anxiety Disorder Sca…
An exploratory, prospective, open-label trial of ingenol mebutate gel 0.05% for the treatment of external anogenital warts
2017
BACKGROUND Anogenital warts (AGW) can cause physical discomfort and decreased quality of life. Recent case reports suggest that ingenol mebutate gel might be an effective treatment of AGW. OBJECTIVE To explore primarily the safety, and secondarily the efficacy of ingenol mebutate gel 0.05% in patients with AGW. METHODS This was an exploratory, open-label, 1-arm trial of ingenol mebutate gel 0.05% administered up to three times to patients with AGW. Safety was assessed by occurrence and severity of local skin reactions (LSRs) and treatment-related adverse events (AEs). Efficacy was assessed by complete clearance and reduction in AGW count 14 days after last treatment, and recurrence 12 weeks…
Levocetirizine for the treatment of itch in psoriasis patients: An open-label pilot study in a real-world setting.
2019
Itch is the most bothersome symptom in psoriasis, often leading to impaired quality of life. Treatment of psoriasis-induced itch is frequently unsatisfactory as the various therapies employed have a delayed onset of effect. Histamine-1 receptor (H1) antihistamines are not recommended in treatment guidelines as histamine is not considered a key mediator in psoriasis. However, patients using H1 antihistamines frequently report benefits in questionnaire-based studies. To address these contradictions, we examined the short-term effects of levocetirizine, a nonsedating H1 antihistamine, on psoriasis-related itch and itch-related quality of life. In this pilot study, patients with psoriasis-relat…
A phase I, open-label, dose-escalation trial of BI 764532, a DLL3/CD3 bispecific antibody, in patients (pts) with small cell lung carcinoma (SCLC) or…
2021
TPS8588 Background: First-line standard of care for pts with metastatic SCLC and neuroendocrine carcinoma (NEC) is platinum-based chemotherapy ± immunotherapy. While the addition of anti-PD1 antibodies has improved outcomes, nearly all pts relapse and prognosis is poor. There is a major unmet need for additional treatment (tx) options. BI 764532 is a delta-like ligand 3 (DLL3)/CD3 T cell engaging bispecific antibody. DLL3 is expressed on the cell surface of many SCLC and NEC tumors, but not on normal cells. In preclinical studies, BI 764532 induced cytotoxicity of DLL3-positive cells and showed anti-tumor activity in animal models. Methods: NCT04429087 is a first-in-human, open-label, dose…