An open-label, Phase I/II trial to determine the maximum tolerated doseand investigate safety, pharmacokinetics and efficacy of BI 836858 incombination with decitabine in patients with acute myeloid leukemia - -

Start Date23 Nov 2017

Sponsor / Collaborator

Boehringer Ingelheim Italia SpA

EUCTR2015-004412-38-IT / Not yet recruitingPhase 3

RE-SPECT CVT: a randomised, open-label, exploratory trial with blinded endpoint adjudication (PROBE), comparing efficacy and safety of oral dabigatran etexilate versus oral warfarin in patients with cerebral venous and dural sinus thrombosis over a 24-week period - RE-SPECT CVT

Start Date22 Nov 2016

Sponsor / Collaborator

Boehringer Ingelheim Italia SpA

EUCTR2015-005438-24-IT / Not yet recruitingPhase 2

A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy and safety of orally administered BI 425809 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer¿s Disease. - -

Start Date15 Sep 2016

Sponsor / Collaborator

Boehringer Ingelheim Italia SpA

100 Clinical Results associated with Boehringer Ingelheim Italia SpA

0 Patents (Medical) associated with Boehringer Ingelheim Italia SpA

Literatures (Medical) associated with Boehringer Ingelheim Italia SpA

01 Apr 2021·ERJ Open Research

Study design of a randomised, placebo-controlled trial of nintedanib in children and adolescents with fibrosing interstitial lung disease

Article

Author: Schwerk, Nicolaus ; Deutsch, Gail ; DeBoer, Emily M ; Verri, Daniela ; Brown, Kevin K ; Deterding, Robin ; Flaherty, Kevin R ; Warburton, David ; Clement, Annick ; Schlenker-Herceg, Rozsa ; Stowasser, Susanne ; Clerisme-Beaty, Emmanuelle ; Griese, Matthias ; Cunningham, Steven ; Dumistracel, Mihaela ; Tetzlaff, Kay ; Young, Lisa R ; Schmid, Ulrike ; Voss, Florian ; Schiwek, Marilisa

Childhood interstitial lung disease (chILD) comprises >200 rare respiratory disorders, with no currently approved therapies and variable prognosis. Nintedanib reduces the rate of forced vital capacity (FVC) decline in adults with progressive fibrosing interstitial lung diseases (ILDs). We present the design of a multicentre, prospective, double-blind, randomised, placebo-controlled clinical trial of nintedanib in patients with fibrosing chILD (1199-0337 or InPedILD;ClinicalTrials.gov:NCT04093024).Male or female children and adolescents aged 6–17 years (≥30; including ≥20 adolescents aged 12–17 years) with clinically significant fibrosing ILD will be randomised 2:1 to receive oral nintedanib or placebo on top of standard of care for 24 weeks (double-blind), followed by variable-duration nintedanib (open-label). Nintedanib dosing will be based on body weight-dependent allometric scaling, with single-step dose reductions permitted to manage adverse events. Eligible patients will have evidence of fibrosis on high-resolution computed tomography (within 12 months of their first screening visit), FVC ≥25% predicted, and clinically significant disease (Fan score of ≥3 or evidence of clinical progression over time). Patients with underlying chronic liver disease, significant pulmonary arterial hypertension, cardiovascular disease, or increased bleeding risk are ineligible. The primary endpoints are pharmacokinetics and the proportion of patients with treatment-emergent adverse events at week 24. Secondary endpoints include change in FVC% predicted from baseline, Pediatric Quality of Life Questionnaire, oxygen saturation, and 6-min walk distance at weeks 24 and 52. Additional efficacy and safety endpoints will be collected to explore long-term effects.

01 Feb 2021·Lung Cancer

Afatinib in EGFR TKI-naïve patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer: Interim analysis of a Phase 3b study

Article

Author: Novello, Silvia ; Egorova, Inna ; Laktionov, Konstantin K ; Metro, Giulio ; Migliorino, Maria Rita ; Schumacher, Michael ; Passaro, Antonio ; Kowalski, Dariusz ; Mukhametshina, Guzel Z ; Cseh, Agnieszka ; Poltoratskiy, Artem ; Dziadziuszko, Rafal ; de Marinis, Filippo ; Hochmair, Maximilian ; Tang, Wenbo ; Clementi, Laura ; Tsoi, Daphne ; Ostoros, Gyula ; Rizzato, Simona ; Gottfried, Maya

OBJECTIVESRandomized controlled trials have demonstrated that afatinib is a suitable treatment option for patients with epidermal growth factor receptor mutation-positive (EGFRm +) non-small cell lung cancer (NSCLC). However, such studies often exclude patients treated in routine clinical practice. We report interim results from a Phase 3b, open-label, multicenter, single-arm, exploratory trial, in which afatinib was investigated in a real-world setting.MATERIALS AND METHODSPatients with EGFRm + tyrosine kinase inhibitor (TKI)-naïve NSCLC received afatinib 40 mg orally, once-daily, until disease progression, or voluntary withdrawal. Primary objective was safety.RESULTSOverall, 479 patients received afatinib: median age 65 years, 8 % of patients had an ECOG performance status ≥ 2, 17 % had brain metastases, and 13 % had tumors containing uncommon mutations only. All but one patient (99.8 %) had an adverse event (AE). Treatment-related AEs (TRAEs; any/grade ≥ 3) occurred in 97 %/44 % of patients; most common were diarrhea (87 %/16 %) and rash (51 %/11 %). AEs leading to afatinib dose-reduction were reported in 258 patients (54 %), and 37 patients (8 %) discontinued treatment due to a TRAE. Objective response rate was 45.5 %, median duration of response was 14.1 months (95 % CI: 12.2-16.4). Overall median time to symptomatic progression and progression-free survival were 14.9 months (95 % CI: 13.8-17.6) and 13.4 months (95 % CI: 11.8-14.5), respectively, in the overall population and 19.3 months (95 % CI: 15.6-21.8) and 15.9 months (95 % CI: 13.9-19.1) in patients with EGFR exon 19 deletions.CONCLUSIONSAfatinib administration in routine clinical practice was well tolerated with no new safety signals and demonstrated promising efficacy in patients with EGFRm + NSCLC. TRAEs were generally manageable with tolerability-guided dose reductions. Overall, these data independently support findings from randomized controlled trials of afatinib in EGFRm + NSCLC.

01 May 2020·A37. ILD THERAPY I

Study Design of a Phase III, Randomized, Placebo-Controlled Trial of Nintedanib in Children and Adolescents with Clinically Significant Fibrosing Interstitial Lung Disease (ILD)

Author: Warburton, D. ; Cunningham, S. ; Griese, M. ; Brown, K.K. ; Deterding, R.R. ; Clerisme-Beaty, E.M. ; Schlenker-Herceg, R. ; Clement, A.F. ; Schmid, U. ; Flaherty, K.R. ; DeBoer, E. ; Verri, D. ; Stowasser, S. ; Deutsch, G. ; Young, L. ; Voss, F. ; Schwerk, N.

100 Deals associated with Boehringer Ingelheim Italia SpA

100 Translational Medicine associated with Boehringer Ingelheim Italia SpA

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