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Published in 2024 at "American Journal of Hematology"
DOI: 10.1002/ajh.27493
Abstract: Autoimmune hemolytic anemia (AIHA) is a group of acquired autoimmune disorders characterized by red blood cell hemolysis. In a phase 2, open‐label, multicenter study, adults with warm AIHA, cold agglutinin disease, or mixed‐type AIHA were…
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Keywords:
treatment;
phase open;
autoimmune hemolytic;
hemolytic anemia ... See more keywords
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Published in 2023 at "Clinical pharmacology in drug development"
DOI: 10.1002/cpdd.1250
Abstract: Zanubrutinib is a second-generation Bruton tyrosine kinase inhibitor that is primarily metabolized by CYP3A enzymes. Previous drug-drug interaction (DDI) studies have demonstrated that co-administration of zanubrutinib with rifampin, a strong CYP3A inducer, reduces zanubrutinib plasma…
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Keywords:
open label;
zanubrutinib;
drug drug;
phase open ... See more keywords
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Published in 2024 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1495
Abstract: Pharmacokinetic (PK) studies pose unique technical challenges. We present the design of a Phase 1, open‐label, fixed‐sequence, PK trial that aimed to compare the timing accuracy of participant‐ versus staff‐collected data, and we provide safety…
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Keywords:
ecgs vital;
vital signs;
phase open;
blood ... See more keywords
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Published in 2018 at "Cancer Chemotherapy and Pharmacology"
DOI: 10.1007/s00280-018-3540-9
Abstract: Combining sorafenib and eribulin mesylate may provide synergistic antitumor activities with limited overlapping toxicities. This phase 1b, open-label, dose-escalation study evaluated safety, pharmacokinetics, maximum tolerated dose/recommended phase 2 dose (MTD/RP2D), and preliminary efficacy of sorafenib…
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Keywords:
open label;
dose escalation;
phase open;
label dose ... See more keywords
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Published in 2019 at "Investigational New Drugs"
DOI: 10.1007/s10637-019-00768-6
Abstract: SummaryPurpose Brentuximab vedotin (BV) is an anti-CD30 antibody-drug conjugate used in the treatment of several types of lymphomas. Expression of the target antigen has also been reported on a variety of malignant tumors of nonlymphoid…
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Keywords:
solid tumors;
study;
phase open;
open label ... See more keywords
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Published in 2019 at "Investigational New Drugs"
DOI: 10.1007/s10637-019-00872-7
Abstract: Background The third-generation tyrosine kinase inhibitor lorlatinib is approved for the treatment of ALK-positive metastatic NSCLC. CYP3A plays a major role in lorlatinib metabolism; therefore, a drug-drug interaction study was warranted to evaluate the impact…
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Keywords:
healthy participants;
period;
study;
phase open ... See more keywords
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Published in 2024 at "International Journal of Hematology"
DOI: 10.1007/s12185-024-03761-9
Abstract: Ibrutinib is a first-in-class Bruton kinase inhibitor against B-cell neoplasms including Waldenström macroglobulinemia (WM). This study evaluated the efficacy and safety of ibrutinib-rituximab in Japanese patients with WM. Patients received ibrutinib 420 mg orally once…
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Keywords:
japanese patients;
ibrutinib rituximab;
phase open;
analysis ... See more keywords
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Published in 2021 at "Dermatology and Therapy"
DOI: 10.1007/s13555-021-00490-3
Abstract: Although many biologic therapies are effective for clearing skin of patients with psoriasis, some lose effectiveness over time. This phase 2 open-label extension (OLE) trial was designed to investigate the long-term safety and efficacy of…
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Keywords:
week;
trial;
safety;
efficacy ... See more keywords
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Published in 2017 at "Neuro-oncology"
DOI: 10.1093/neuonc/nox168.061
Abstract: BACKGROUND c-MET and PI3K pathways are dysregulated in GBM and can drive cancer growth in pre-clinical models. INC280 is a small molecule inhibitor of c-MET; BKM120 is a pan-class I PI3K inhibitor. A phase Ib/II study was designed…
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Keywords:
phase;
bkm120;
study;
phase open ... See more keywords
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Published in 2020 at "IEEE Access"
DOI: 10.1109/access.2020.3024736
Abstract: A fault tolerant control strategy for dual three-phase permanent magnet synchronous motor (DTP-PMSM) with 0° phase shifting between two windings is proposed in this paper. When a DTP-PMSM suffers from single- or two-phase open-circuit fault,…
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Keywords:
phase shifting;
phase open;
single two;
two phase ... See more keywords
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Published in 2022 at "IEEE Access"
DOI: 10.1109/access.2022.3176019
Abstract: This paper proposes hybrid mode control for an asymmetric dual three-phase synchronous motor (ADTP-SM) with separated neutral points in a single-phase open-fault situation. The fault-tolerant control is classified into the maximum torque mode and minimum…
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Keywords:
control;
phase open;
phase;
mode ... See more keywords