14 results
Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…
Primary Objective: - To establish the population range (24-h AUC) of high-dose infusional 5-FU in patients with locally advanced, resectable gastric or gastro-esophageal junction cancer treated with perioperative FLOT.Secondary objectives: - To…
To prospectively explore the feasibility safety, tolerability, preliminary efficacy, costs, and pharmacokinetic profile of repetitive ePIPAC-OX as a palliative monotherapy for isolated unresectable colorectal PM under controlled circumstances.
The main trial objectives are to demonstrate a non-flat dose response curve, to evaluate the size of the treatment effect (using the absolute difference in proportions of patients with histological improvement between BI 456906 and placebo at week…
Primary objectiveTo confirm the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, in subjects with T1D. This includes comparing the difference in change from baseline in HbA1c between once weekly insulin…
To examine the effect of two different degludec dose adjustments on glucose profiles and the incidence of (nocturnal) hypoglycaemia after oxidative exercise in people with DM1 at elevated risk of hypoglycaemia.
To demonstrate the noninferiority of insulin glargine 300 U/mLin comparison to insulin degludec 100 U/mL on glycemiccontrol and variability in participants with diabetes mellitus
Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…
Primary objective:To determine the percentage of the patients that achieve optimal 5-FU exposure within two dose cycles of 5-FU, which is defined by an AUC target of 5-FU between 20 and 30 mg h/L or dose limiting toxicity.Secondary objectives:-To…
To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
Primary Objectives:-To evaluate if the treatment of Low Risk HB can be reduced (Group B1)-To compare different induction treatment regimens for Intermediate risk HB (Group C)-To compare different post induction treatment regimens for High Risk HB (…
Main Objective (EudraCT):To evaluate the safety and tolerability of RO7198457 when administered as a single agent (Phase [Ph] Ia) or in combination with atezolizumab (Ph Ib), with or without prophylactic treatment with corticosteroids, including…
The aim of this study is to prove feasibility of HAIP chemotherapy (floxuridine) in combination with standard systemic chemotherapy consisting of FOLFOX or FOLFIRI.