25 results
Primary: to estimate progression-free survival in patients treated with everolimus + letrozole in the first line setting.Secondary: overall response rate, clinical benefit rate, overall survival in the first line setting, progression free survival…
To describe and compare pharmacokinetics of everolimus in a 10 mg QD and everolimus 5mg BID schedule, evaluated PK parameters will be a.o. Cmax/Cmin ratio, AUC, Cmax, Cmin, Tmax.
The primary objective is to assess safety and efficacy of abiraterone acetate plus prednisone and abiraterone acetate plus prednisone plus exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer…
To characterize the clearance pathways, the routes of excretion, total recovery of radioactivity, pacritinib and its major metabolites in healthy subjects following administration of a single oral dose of 400 mg [14C]pacritinibTo characterize the…
A phase Ib / II randomized study of BI 836845 in combination with exemestane and everolimus versus exemestane and everolimus alone in women with locally advanced or metastatic breast cancer.With following objectives:Phase Ib part: To determine the…
To compare the combination treatment of everolimus and exemestane to exemestane alone with respect to progression-free survival in postmenopausal women with estrogen receptor positive breast cancer that is refractory to non-steroidal aromatase…
This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time…
The objective of this study is to assess efficacy and safety of radium 223 dichloride in combination with exemestane and everolimus in subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor positive breast cancer…
Objecive of phase I was the determination of the maximum tolerated dose (MTD) and recommended phase II dose of BI836845 in combination with exemestane and everolimus in women with HR+ / HER2- locally advanced or metastatic breast cancer.Ojective of…
To assess the efficacy of AZD9291 compared to placebo as measured by disease free survival (DFS)Protocol v1.0, 4Jun2015, p30
To investigate the effect of a CYP3A4 inducer (rifampicin) on the PK of AZD9291.
To investigate the effect of a CYP3A4 inhibitor (itraconazole) on the PK of AZD9291.
The main objective of this pilot study is to determine the intratumoral concentrations of osimertinib upon 1 week of treatment in peritoneal metastasis of patients who are candidate for CRS-HIPEC treatment (group 1) and in liver metastasis of…
To assess uptake of 11C-osimertinib in tumor lesions of T790M double positive patients and T790M double negative patients, thereby evaluating specific and aspecific (off-target) 11C-osimertinib accumulation in tumor tissue.
Primary objectiveTo assess the efficacy of the combination of osimertinib and bevacizumab versus osimertinib alone in terms of progression-free survival (PFS) assessed by RECIST 1.1.Secondary Objectives:To compare short and long term clinical…
Primary objectives• To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.• To determine the success rate of crizotinib and osimertinib combination…
• to assess the efficacy of the sequential combination strategy of front-line afatinib-chemo, followed by a treatment with osimertinib-chemo in those patients that develop a T790M mutation as a mechanism of resistance.
Main objective:•To compare the progression-free survival of imlunestrant (Arm A) to the standard comparator of Investigator's Choice Endocrine Therapy of either fulvestrant or exemestane (Arm B) in the ITT population•To compare the PFS of Arm…
The main objective of this study is to assess the efficacy of tepotinib combined with osimertinib inparticipants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.The secondary objectives are the following:…
Primary objective:- To assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS in patients with subset of T1 to T3N0 NSCLCOsimertinib cohort:- To assess the efficacy of osimertinib following SoC SBRT by 4…