13 results
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.
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…
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…
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…
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 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…
This study aims to evaluate the predictive ability of the muscle fatiguability test to predict recovery in older adults admitted to the department of geriatric medicine. Recovery is defined as length of stay, daily functioning after 3 and 6 months…
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 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.
Primary Objectives1. to establish the safety of intravenous administration of a therapeutic peptideamount of the CP042. to assess the biodistribution and dosimetry of 111In-CP04 in cancer and normal tissues and to determine critical organs.Secondary…
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…
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,…