Search results for "Open label"
showing 8 items of 28 documents
Regorafenib for previously treated metastatic colorectal cancer (mCRC): results from 683 Italian patients treated in the open-label phase IIIB CONSIG…
2015
A randomized, multicenter, open-label controlled phase 2 trial of Foxy-5 as neoadjuvant therapy in patients with WNT5A negative colon cancer
2019
A phase IB, multicenter, open-label study to assess the safety, tolerability, and efficacy of the pleiotropic pathway modifier CC122 administered ora…
2017
379 Background: CC122 is a novel cereblon-modulating agent with multiple biologic activities including potent immunomodulatory and antiangiogenic effects. CC-122 binding to cereblon promotes ubiquitination and subsequent degradation of lymphoid transcription factors Ikaros and Aiolos resulting in activation of T cells. Methods: Following establishment of oral CC122 3 mg daily (QD) as the MTD in phase 1a (Blood 122:2905 2013), an expansion cohort of advanced Hepatocellular Carcinoma (HCC) subjects was enrolled. All subjects had progressed on or were intolerant to sorafenib. Efficacy was assessed per RECIST 1.1 criteria. Results: As of Jan. 13, 2016, 25 advanced HCC subjects were enrolled. T…
An Analysis of “No Effect of Insulin Pen with Memory Function on Glycemic Control in a Patient Cohort with Poorly Controlled Type 1 Diabetes: A Rando…
2012
Missing meal bolus and nonadherence is an important barrier to achieving glycemic goals in type 1 diabetes (T1DM). In this issue of Journal of Diabetes Science and Technology, Danne and coauthors reported the results of a 24-week randomized-controlled study designed to evaluate if using an insulin pen with memory function, the HumaPen® Memoir™, might improve injection compliance and, therefore, overall glycemic control in T1DM. Patients treated with the pen device with memory function improved, albeit nonsignificantly, their mean HbA1c by 0.43%. Among the reasons to justify why this study was not positive, the most important is the high proportion of adult patients included in the study (87…
685 EFFICACY OF INTRANASAL FENTANYL SPRAY (INFS) VERSUS ORAL TRANSMUCOSAL FENTANYL CITRATE (OTFC) FOR BREAKTHROUGH CANCER PAIN: OPEN‐LABEL CROSSOVER …
2009
DOP41 Efficacy and safety of open-label treatment with tofacitinib 10 mg twice daily in patients with ulcerative colitis with clinical response, but …
2019
Long-Term Outcomes with Subcutaneous C1-Inhibitor Replacement Therapy for Prevention of Hereditary Angioedema Attacks: An Open-Label Extension Study …
2018
A Single-Arm, Open-Label Phase 1 Study of Itacitinib (ITA) with Calcineurin Inhibitor (CNI)-Based Interventions for Prophylaxis of Graft-Versus-Host …
2020
Background Despite prophylaxis, GVHD remains a significant cause of morbidity and nonrelapse mortality after allogeneic hematopoietic cell transplantation (HCT). ITA is a potent, selective Janus kinase (JAK) 1 inhibitor that has been combined safely with steroids in patients (pts) with acute GVHD. We describe results from a proof-of-concept study evaluating ITA + CNI-based regimens for GVHD prophylaxis. Study Design and Methods GRAVITAS-119 (NCT03320642) was a single-arm, open-label study enrolling pts aged ≥18 y undergoing allogeneic HCT using peripheral blood stem cells from 8/8 or 7/8 matched related or unrelated donors for a hematologic malignancy. Eligible pts were candidates for reduc…