An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) - FIBRONEER™-ON

开始日期2025-02-07

申办/合作机构

Boehringer Ingelheim GmbH

[+1]

CTRI/2024/01/061469 / Active, not recruiting临床3期

An open-label, multicenter, single-arm, post-marketing trial (in select countries) to evaluate efficacy and safety and the impact of immunogenicity on efficacy, safety, and pharmacokinetics of spesolimab i.v. in treatment of patients with Generalized Pustular Psoriasis presenting with a recurrent flare following their initial GPP flare treatment with spesolimab i.v - NIL

开始日期2024-03-02

申办/合作机构

Boehringer Ingelheim GmbH

[+1]

CTRI/2024/01/061497 / Recruiting临床3期

A Phase 3, randomised, double-blind, parallel-group, eventdriven, cardiovascular safety study with BI 456906 administered subcutaneously compared with placebo in participants with overweight or obesity with established cardiovascular disease (CVD) or chronic kidney disease, and/or at least two weightrelated complications or risk factors for CVD - NIL

开始日期2024-02-28

申办/合作机构

Boehringer Ingelheim GmbH

[+1]

100 项与 IQVIA RDS (India) Pvt Ltd. 相关的临床结果

登录后查看更多信息

0 项与 IQVIA RDS (India) Pvt Ltd. 相关的专利（医药）

登录后查看更多信息

项与 IQVIA RDS (India) Pvt Ltd. 相关的文献（医药）

2023-04-01·Perspectives in Clinical Research

Impact of COVID-19 on management of clinical trials and the potential mitigating strategies

Article

作者: Chetule, Charulata ; Tattu, Sarvajnya ; Sarve, Parag ; Gawali, Vijaykumar ; Ali, Heena

2022-08-01·The Breast2区 · 医学

Safety and efficacy of adjuvant subcutaneous trastuzumab in human epidermal growth factor receptor 2-positive early breast cancer: Final results of the SafeHER study

2区 · 医学

ArticleOA

作者: Restuccia, Eleonora ; Alexandrou, Ari ; Tosti, Nadia ; Jung, Kyung Hae ; De Laurentiis, Michelino ; Gupta, Kushagra ; Pivot, Xavier ; Gligorov, Joseph ; Ataseven, Beyhan ; Abdel Azim, Hamdy ; Manikhas, Alexey ; Herraez-Baranda, Luis

AIMTo report the final results of the 5-year follow-up of the non-randomized SafeHER Phase III study (NCT01566721) describing the safety, tolerability, and efficacy of subcutaneous (SC) trastuzumab alone and in combination with concurrent or sequential chemotherapy.METHODSPatients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) with no prior anti-HER2 therapy were included. SC trastuzumab was administered every 3 weeks for 18 cycles as adjuvant therapy with or without chemotherapy (concurrent or sequential). The primary objective was overall safety and tolerability of SC trastuzumab; efficacy was a secondary objective.RESULTSNo new safety signals were observed during the final evaluation. The majority of adverse events (AEs) were grade 1 or 2 across the chemotherapy subgroups. Treatment discontinuation due to AEs was 5.1% for the intent-to-treat (ITT) population and similar for all chemotherapy subgroups. The overall disease-free survival (DFS) 5-year event-free rate in the ITT population (n = 2573) was 86.6% (95% CI, 85.2%-87.9%) with a median follow-up of 72 months. Based on chemotherapy timing, the no (n = 235), concurrent (n = 1533), and sequential (n = 805) chemotherapy subgroups had DFS 5-year event-free rates (95% CI) of 88.5% (83.4%-92.2%), 88.4% (86.6%-89.9%), and 82.6 (79.7%-85.2%), respectively.CONCLUSIONSThe 5-year follow-up analysis of the SafeHER trial demonstrating that SC trastuzumab has an acceptable safety profile, including cardiac toxicity, and efficacy for the treatment of HER2-positive EBC with and without chemotherapy, corresponding with historical data with trastuzumab.

2021-12-01·Clinical Breast Cancer3区 · 医学

Impact of Anti-HER2 Treatments Combined With Atezolizumab on the Tumor Immune Microenvironment in Early or Metastatic Breast Cancer: Results From a Phase Ib Study

3区 · 医学

Article

作者: Hamilton, Erika P ; Chui, Stephen Y ; Molinero, Luciana ; Rotmensch, Jacob ; Patre, Monika ; Li, Yijin ; Ward, Patrick J ; Emens, Leisha A ; Kaklamani, Virginia ; Falkson, Carla ; Vidal, Gregory A ; Gupta, Kushagra

BACKGROUNDDespite advances, there continues to be unmet need in breast cancer. Combining anti-programmed death-ligand 1 (PD-L1) cancer immunotherapy atezolizumab with other targeted therapies may enhance T-cell-dependent cytolytic antitumor activity.METHODSThis open-label, phase Ib study evaluated the safety of atezolizumab-based combinations with antibody-dependent cellular cytotoxicity or antibody-drug conjugate (ADC) agents. Patients with unresectable human epidermal growth factor receptor 2-positive (HER2⁺) locally advanced or metastatic breast cancer (mBC) received atezolizumab with trastuzumab/pertuzumab, atezolizumab with the ADC ado-trastuzumab emtansine (T-DM1), or atezolizumab with trastuzumab/pertuzumab and docetaxel. In an early-breast cancer (eBC) "window of opportunity" study, patients with operable HER2⁺ locally advanced or inflammatory eBC received neoadjuvant atezolizumab with trastuzumab/pertuzumab or atezolizumab/T-DM1, followed by docetaxel, carboplatin, and trastuzumab/pertuzumab. Exploratory outcomes included tumor response and biomarkers.RESULTSBy March 15, 2019, 73 patients were enrolled. Safety findings were consistent with the treatment components' individual profiles. Objective responses were observed in 2 of 6 and 5 of 14 patients in 2 mBC cohorts receiving atezolizumab/T-DM1 and in 6 of 6 patients with mBC receiving atezolizumab, trastuzumab/pertuzumab, and docetaxel. PD-L1 in immune cells was the only biomarker that increased with atezolizumab/T-DM1. In the window of opportunity cohorts, PD-L1 levels and CD8⁺ T-cell infiltration increased from baseline in HER2⁺ eBC tumors receiving atezolizumab with trastuzumab/pertuzumab or T-DM1, irrespective of response. Despite increases in T-cell and B-cell gene signatures with trastuzumab/pertuzumab, but not T-DM1, neither combination promoted T-cell receptor clonal expansion.CONCLUSIONAtezolizumab with antibody-dependent cellular cytotoxicity or ADC agents appears safe and may activate the adaptive immune system of patients with HER2⁺ eBC tumors more than those with mBC tumors.

100 项与 IQVIA RDS (India) Pvt Ltd. 相关的药物交易

登录后查看更多信息

100 项与 IQVIA RDS (India) Pvt Ltd. 相关的转化医学

登录后查看更多信息