Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)

Start Date08 May 2017

Sponsor / Collaborator

SCS Boehringer Ingelheim Comm.V

EUCTR2015-003625-34-BE / Not yet recruitingPhase 2

A randomised, double-blind, placebo-controlled, proof-of-concept, dose-ranging study of BI 655066 in patients with active psoriatic arthritis

Start Date04 May 2016

Sponsor / Collaborator

SCS Boehringer Ingelheim Comm.V

EUCTR2014-000904-88-BE / Not yet recruitingPhase 4

A 24 week randomized, double-blind, placebo-controlled, parallel group, efficacy and safety trial of once daily linagliptin, 5 milligrams orally, as add on to basal insulin in elderly Type 2 Diabetes Mellitus patients with insufficient glycaemic control

Start Date23 Sep 2014

Sponsor / Collaborator

SCS Boehringer Ingelheim Comm.V

100 Clinical Results associated with SCS Boehringer Ingelheim Comm.V

0 Patents (Medical) associated with SCS Boehringer Ingelheim Comm.V

Literatures (Medical) associated with SCS Boehringer Ingelheim Comm.V

01 Jul 2023·European journal of cancer (Oxford, England : 1990)

Afatinib in paediatric patients with recurrent/refractory ErbB-dysregulated tumours: Results of a phase I/expansion trial

Article

Author: Nysom, Karsten ; Fu, Eric ; Amoroso, Loredana ; Geoerger, Birgit ; Marshall, Lynley V ; Bouffet, Eric ; Solca, Flavio ; Lorence, Robert M ; Leblond, Pierre ; Aerts, Isabelle ; Makin, Guy ; Van-Vlerken, Kim ; Defachelles, Anne-Sophie ; Barahona, Paulette ; Ziegler, David S

AIMThis phase I/expansion study assessed the safety, pharmacokinetics and preliminary antitumor activity of afatinib in paediatric patients with cancer.METHODSThe dose-finding part enroled patients (2-<18 years) with recurrent/refractory tumours. Patients received 18 or 23 mg/m²/d afatinib orally (tablet or solution) in 28-d cycles. In the maximum tolerated dose (MTD) expansion, eligible patients (1-<18 years) had tumours fulfilling ≥2 of the following criteria in the pre-screening: EGFR amplification; HER2 amplification; EGFR membrane staining (H-score>150); HER2 membrane staining (H-score>0). The primary end-points were dose-limiting toxicities (DLTs), afatinib exposure, and objective response.RESULTSOf 564 patients pre-screened, 536 patients had biomarker data and 63 (12%) fulfilled ≥2 EGFR/HER2 criteria required for inclusion in the expansion part. A total of 56 patients were treated (17 in the dose-finding and 39 in the expansion part). DLTs were observed in one of six MTD-evaluable patients receiving 18 mg/m²/d and in two of five MTD-evaluable patients receiving 23 mg/m²/d; 18 mg/m²/d was defined as the MTD. There were no new safety signals. Pharmacokinetics confirmed exposure consistent with the approved dose in adults. One partial response (-81% per Response Assessment in Neuro-Oncology) was observed in a patient with a glioneuronal tumour harbouring a CLIP2::EGFR fusion; unconfirmed partial responses were observed in two patients. In total, 25% of patients experienced objective response or stable disease (95% confidence interval: 14-38).CONCLUSIONTargetable EGFR/HER2 drivers are rare in paediatric cancers. Treatment with afatinib led to a durable response (>3 years) in one patient with a glioneuronal tumour with CLIP2::EGFR fusion.

01 Dec 2022·Respiratory ResearchQ2 · MEDICINE

Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial

Q2 · MEDICINE

ArticleOA

Author: Cottin, Vincent ; Martinez, Fernando J ; Belperio, John A ; Tschoepe, Inga ; Costabel, Ulrich ; Lievens, Dirk ; Molina-Molina, Maria ; Coeck, Carl ; Jenkins, R Gisli ; Kitamura, Hideya

AbstractBackgroundIn the INBUILD trial in patients with progressive fibrosing interstitial lung diseases (ILDs), nintedanib reduced the rate of decline in forced vital capacity compared with placebo, with side-effects that were manageable for most patients. We used data from the INBUILD trial to characterize further the safety and tolerability of nintedanib.MethodsPatients with fibrosing ILDs other than idiopathic pulmonary fibrosis (IPF), who had experienced progression of ILD within the 24 months before screening despite management deemed appropriate in clinical practice, were randomized to receive nintedanib 150 mg twice daily or placebo. To manage adverse events, treatment could be interrupted or the dose reduced to 100 mg twice daily. We assessed adverse events and dose adjustments over the whole trial.ResultsA total of 332 patients received nintedanib and 331 received placebo. Median exposure to trial drug was 17.4 months in both treatment groups. Adverse events led to treatment discontinuation in 22.0% of patients treated with nintedanib and 14.5% of patients who received placebo. The most frequent adverse event was diarrhea, reported in 72.3% of patients in the nintedanib group and 25.7% of patients in the placebo group. Diarrhea led to treatment discontinuation in 6.3% of patients in the nintedanib group and 0.3% of the placebo group. In the nintedanib and placebo groups, respectively, 48.2% and 15.7% of patients had ≥ 1 dose reduction and/or treatment interruption. Serious adverse events were reported in 44.3% of patients in the nintedanib group and 49.5% of patients in the placebo group. The adverse event profile of nintedanib was generally consistent across subgroups based on age, sex, race and weight, but nausea, vomiting and dose reductions were more common among female than male patients.ConclusionsThe adverse event profile of nintedanib in patients with progressive fibrosing ILDs other than IPF is consistent with its established safety and tolerability profile in patients with IPF and characterized mainly by gastrointestinal events, particularly diarrhea. Management of adverse events using symptomatic therapies and dose adjustment is important to minimize the impact of adverse events and help patients remain on therapy.Trial registration Registered 21 December 2016, https://clinicaltrials.gov/ct2/show/NCT02999178Graphical AbstractA video abstract summarizing the key results presented in this manuscript is available at: https://www.globalmedcomms.com/respiratory/cottin/INBUILDsafety.

01 May 2022·62. Kongress der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin e. V.

Continued nintedanib treatment in patients with progressive fibrosing ILDs: interim analysis of INBUILD-ON*

Author: Rohr, K B ; Antin-Ozerkis, D ; Cottin, V ; Bonella, F ; Coeck, C ; Wuyts, W A ; Varone, F ; Mueller, H ; Chaudhuri, N

100 Deals associated with SCS Boehringer Ingelheim Comm.V

100 Translational Medicine associated with SCS Boehringer Ingelheim Comm.V

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