42 results
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…
This will be the first study with JNJ-63733657 in humans to investigate the safety, tolerability and pharmacokinetics of JNJ-63733657 and to explore potential pharmacodynamic (PD) effects in healthy subjects following single dose administration and…
The primary objectives for this study are:To evaluate the preventive effect of GYM329 on disuse muscle atrophy in healthy male volunteers through changes in muscle strength following a single subcutaneous administration prior to unilateral thigh and…
Primary ObjectivesPart 1:To characterize the safety and tolerability of single ascending doses of PTC518 in healthy subjects.Part 2:To characterize the safety and tolerability of PTC518 administered for 14 or up to 21 days in healthy subjects.Part 3…
PrimaryTo evaluate the safety and tolerability of single and multiple doses of TBAJ-587 in healthy participants.SecondaryTo determine the pharmacokinetics (PK) of single and multiple doses of TBAJ-587 and metabolites M2, M3 and M12. To compare the…
To investigate the safety and tolerability of GSK2556286 after single ascending and repeat oral doses in healthy adult participants.To determine the pharmacokinetics of single and repeat oral doses of GSK2556286 in healthy participants.To assess the…
To assess the safety and tolerability profile of escalating dose levels of ESB1609 when administered as once daily (qd) oral doses for up to 25 days in healthy volunteers.
To generate high quality empirical evidence for the effectiveness in terms of proportion of patients experiencing complications, quality of life and costs of initial non-operative treatment strategy (reserving appendectomies for those not responding…
This proof-of-mechanism (POM) study in subjects with early AD, being subjects asymptomatic at risk for AD and subjects with pAD, is performed to confirm a drug interaction with the intended enzyme (BACE) at the intended target location (brain) by…
The objective of this study is to evaluate the effect of cabozantinib compared with everolimus on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine…
Phase Ib:Estimate the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of AEB071 and everolimus combination therapy inpatients with DLBCLPhase II:Assess the preliminary evidence for anti-tumor activity at R2PD for AEB071 and…
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 evaluate the efficacy of pasireotide LAR and everolimus alone or in combination in progressive patients with a well differentiated neuroendocrine tumor of the lung or thymus.
Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…
This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.
The main objective of this pilot study is to determine the biological impact of treatment with targeted agents at the systemic and local tissue level in relation to toxicity.
Primary objective: to evaluate safety of everolimus in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer that is refractory to NSAIs.Secondary objective: to evaluate adverse events grade 3 and 4 in the…
To determine the relation between tumor tissue phosphoproteomic profiles and progression-free survival (PFS) in patients with advanced RCC
To determine whether treatment with everolimus 10 mg daily plus best supportive care prolongs PFS compared with placebo plus best supportive care in patients with advanced NET of GI or lung origin without a history of carcinoid symptoms
Primary objectives:- To evaluate the effect of old age (* 70 years) on everolimus pharmacokinetics (AUC0-24hr)- To evaluate the effect of obesity (BMI * 30 kg/m2) on everolimus pharmacokinetics (AUC0-24hr)Secondary objectives:- To evaluate whether…