19 results
Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
The objective of this Phase III study is to evaluate the efficacy and safety of nintedanib in patients with mCRC after failure of previous treatment with standard chemotherapy and biological agents.
Primary: To assess PFS of lung cancer patients with an FGFR1 gene amplified in their tumor cells upon treatment with BIBF1120.Secondary: To assess response rate, duration of response, overall survival and safety.
The primary efficacy objective for this study was to evaluate the efficacy of gantenerumab compared with placebo administered to patients by subcutaneous (SC) injection over 100 weeks as measured by the following co-primary endpoints (final outcome…
To investigate the analgesic profile of different classical and non-classical analgesic compounds using a battery of pain tests (PainCart) in healthy subjects compared to a negative control.Secondary:- Investigate the association between subjective…
To evaluate the safety and efficacy in terms of progression-free survival (PFS) and overall survival (OS) of nintedanib + pemetrexed / cisplatin followed by nintedanib versus placebo + pemetrexed / cisplatin followed by placebo as first line…
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
The objective of the trial is to assess the efficacy and safety of nintedanib in the treatment ofSSc with ILD at a dose of 150 mg bid compared to placebo.
The primary objective is to explore the efficacy of nintedanib (as measured by progression free survival) as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.
The objectives are to assess the efficacy, safety and effect on quality of life of Nintedanib compared to chemotherapy in women with relapsed, advanced or metastatic clear cell cancer of the ovary of endometrium.
The primary objective for this study is to evaluate the safety, tolerability and efficacy of long-term gantenerumab administered by SC injection.
This clinical trial is an open-label extension trial of the main study SENSCISTM (1199.214) and 1199-0340 to further evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis.Also, in this trial,…
This study will evaluate the efficacy and safety of gantenerumab compared with placebo in patients with early (prodromal to mild) Alzheimer's disease (AD).
The primary objective of the trial is to evaluate whether nintedanib given as second-line therapy for advanced, inoperable and/or metastatic STSprolongs progression-free survival when compared with ifosfamide.Secondary objectives are to evaluate the…
The primary objective of this secondary prevention study is to evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of gantenerumab, an anti-amyloid antibody, in amyloid-positive, cognitively unimpaired participants at risk for or…
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD. Additional efficacy and safety endpoints will be collected to explore potential long-term effects.Please see…
The main objective of this study is to continue to collect long-term safety and tolerabilitydata in participants with AD treated with gantenerumab. Specific objectives andcorresponding endpoints for the study are outlined in Table 1 of the protocol
The main objective of the trial is to assess the safety and tolerability of long-term treatment with nintedanib in pediatric patients with clinically significant fibrosing ILD.See section 2.1 and 2.2 of the protocol.