28 results
The aim of the trial is to individualize treatment for each patient by adapting it to early response and thus to continue intensive treatment only with those patients wo show an inadequate treatment response.For patients who show a good initial…
The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed…
To evaluate the effects of COS with tamoxifen or letrozole compared to standard COS, on oocytes retrieved.
Objectives: - to increase the proportion of patients with non-severe GVHD within 180 days post-allo-SCT - to reduce the progression rate - to improve the progression free survival- to asses the impact on the quality of life using a time restricted…
Primary objective* To evaluate the efficacy of IAT in addition to BMM compaed to BMM alone in terms of favourable outcome at 90 days, defined as a modified Rankin score of 0-3, in patients with an acute ischemic stroke caused by basilar artery…
To determine the influence of morning versus evening administration on the pharmacokinetics of tamoxifen and its metabolites. Amendment: To determine the influence of time of administration (morning (8 a.m.), afternoon (1 p.m.) and evening (8 p.m…
- To examine the effects of cytochrome P450 induction by rifampicin on the metabolism and pharmacokinetics of tamoxifen and its metabolites. Induction of cytochrome P450 enzyme expression (including CYP3A4, CYP2C and CYP2D6) by rifampicin will…
The primary objective of the study is:* To evaluate the overall safety and tolerability related to systemic plasminogen activation of single doses of HisproUK (part 1) and sequential administration of tPA and HisproUK (part 2)The secondary…
The ,aim of Wake-Up is to provide a new safe and effective treatment option for acute stroke patients waking up with stroke symptoms or patients with unknown symptom onset. Every year about 2milion patients suffer a stroke in the EU and up to 20% of…
The main objective is: To determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).Secundary objectives are:1. Other pharmacokinetic outcomes (i.e. clearance, minimum…
• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…
Primary objectives-Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years.-Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an out…
The primary objective of the trial is to determine if ischemic stroke subjects with a baseline NIH Stroke Scale Score (NIHSSS] >= 10 (8-9 with positive CTA) treated with recombinant tissue plasminogen activator (rt-PA; [Alteplase recombinant…
Inhibition of CYP2D6 enzymes by SSRIs may lead to reduced endoxifen plasma concentrations and thereby possibly influence tamoxifen treatment outcome. Paroxetine is a potent CYP2D6 inhibitor and strongly reduces endoxifen plasma concentrations.…
The aim of the study is to assess if a dose reduction of craniospinal irradiation in children with a medulloblastoma does not reduce event free survival (EFS) or overall survival (OS). Furthermore it will be assessed if a field reduction (only tumor…
In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…
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…
To compare the plasma concentration of edoxaban in women with breast cancer before and during treatment with tamoxifen.
To determine the influence of concomitant administration of tamoxifen and probenecid on tamoxifen and endoxifen(-glucuronide) plasma concentrations
As of protocol Amendment 06, evaluation of the safety profile of MLN9708 and/or other study medication is the only endpoint being assessed. All other study endpoints will no longer be assessed.