13 results
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…
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 objectiveTo determine the effect of steady state boceprevir on the pharmacokinetics (AUC0-12h, Cmax, C12h) of a single dose raltegravir.Secondary objectives:To determine the effect of a single dose raltegravir on the pharmacokinetics (AUC0-…
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.
RO7009789 and atezolizumab are experimental drugs that are being investigated by F. Hoffmann La Roche Ltd for the treatment of locally advanced and / or metastatic solid tumors.
The main objective is to evaluate the percentage of patients that do not experience progression during the first 18 weeks of treatment with Atezolizumab in patients affected by advanced solid tumors.The secondary objectives are to evaluate the…
Safety ObjectiveThe safety objective for this study is as follows:* To evaluate the safety and tolerability of atezolizumab in pediatric and young adult patients, focusing on the nature, frequency, and severity of serious and non-serious adverse…
The primary objective of this study is to determine the anti-tumor activity, as measured by overall response rate (ORR) of atezolizumab in combination with bevacizumab in patients with chemotherapy resistant CRC and positivity for MSI-like molecular…
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…
Dose-Escalation Stage (Combination Therapy Cohorts):The primary objective is as follows:• To determine the maximum tolerated dose (MTD) and/or recommended dose and schedule for the subsequent Expansion Stage of daily oral administration of…
• Determine the maximum tolerated dose (MTD) and/or recommended dose (RD) for further evaluation of XL092 when administered alone and in combination with ICIs to subjects with advanced solid tumors• Evaluate preliminary efficacy of XL092 when…
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.
This study will evaluate the efficacy and safety of multiple therapies that are selected using somatic alterations and potential predictive biomarkers identified via NGS assays in patients with solid tumors: