16 results
PrimaryTo assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory teratoma with recent progressionSecondaryTo assess other measures of efficacy of LEE011 compared with placebo To assess safety and tolerability of…
To test the suitability of OCT for in vivo imaging of the vascularisation and surrounding tissue of burn wounds and scars.
1) identifying new predictors of ST, in particular of late and very late ST and drug eluting stent thrombosis2) to observe clinical outcome after an episode of a ST
PRIMARY- Phase Ib: To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 regimen (RP2R) of ribociclib and trametinib in patients with solid tumors- Phase II: To assess overall response rate (ORR) with the combination of…
Primary Objective: To investigate if use of OCT is (cost-)effective in the diagnostic work-up of patients with clinically and dermoscopically suspected basal cell carcinoma (BCC).Secondary Objective(s): To explore if OCT is a more patient friendly…
In this study we aim to use minimally invasive real-time techniques including OCT, HHGM, eNose and/or GC-MS for the evaluation of the effect of BT and determine response predictors. To evaluate innovative diagnostic techniques that might be able to…
Primary Objective: To determine the safety and feasibility of pre-operative immunotherapy in CRC. Additional Primary Objective for the expanded the MSI cohort: To assess efficacy of neoadjuvant ipilimumab plus nivolumab in terms of disease-free…
To identify and define characteristics of ILD on the pCLE and pOCT image of airway wall mucosa and the alveolar compartment and compare this to HRCT imaging and pathology.
Primary: To estimate the MTD and/or RDE for each of the following three treatment arms in patients with myelofibrosis.* PIM447 plus ruxolitinib (doublet)* Ribociclib (LEE011) plus ruxolitinib (doublet)* PIM447 plus ruxolitinib and Ribociclib (LEE011…
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…
Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…
Primary objective:• Determine if ribociclib plus letrozole gives a >=100% improvement in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) as compared to chemotherapy in the surgical specimen*.Secondary objective• Study the…
Primary objective of this study: evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR) by local investigator's assessment per RECIST v1.1secondary objectives: - Safety & tolerability of…
To investigate the added value of OCT as a non-invasive tool for the diagnosis of recurrent BCC.
Primary: To compare PFS between ribociclib plus fulvestrant to fulvestrant monotherapy (plus placebo) among men and postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)