18 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…
(1) To phenotype chronic low back pain patients in terms of endogenous modulation of pain, central sensitization/facilitation, and the presence of a neuropathic pain component;(2) To assess the effect of a three-month treatment with tapentadol on…
(1) To phenotype fibromyalgia patients in terms of endogenous modulation of pain, central sensitization/facilitation, the presence of a neuropathic pain component and small fiber neuropathy;(2) To assess the effect of a three-month treatment with…
1. Measure DNIC and offset analgesia in neuropathic pain patients;2. Compare DNIC and offset analgesia in chronic pain patients with DNIC and offset analgesia in healthy volunteers;3. Assess the effect of oral tapentadol on DNIC and offset analgesia…
To evaluate two different placebo intrauterine systems, pentagon-shaped placebo FR01 and traingle-shaped FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.
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…
The main objective is to determine the change in CS parameters upon administration of tapentadol in comparison to pregabalin in patients suffering from chronic pain that has a visceral or deep somatic origin.
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…
To construct the utility surfaces of tapentadol and oxycodone.
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…
The objective of this study is to investigate the extent of respiratory depression at equi-analgesic dosages of tapentadol and oxycodone
The purpose of this study is to investigate how quickly and to what extent two 25 mg prolonged release tapentadol tablets are absorbed and eliminated from the body (this is called pharmacokinetics) when compared to one 50 mg prolonged release…
To prevent the development of chronic postoperative pain after inguinal hernia surgery and knee replacement surgery and to to further explore the mechanism behind the development of chronic postoperative pain.
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: 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…
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 evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)