12 results
To assess the analgesic efficacy, safety, and tolerability of once daily orally administered GRT6005 in a total of 3 fixed doses (i.e., 200 µg, 400 µg, and 600 µg GRT6005) compared to placebo in subjects with moderate to severe chronic LBP.
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
(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…
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
(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…
Primary objectives Phase I: To determine the recommended phase 2 dose (RP2D) of the lapatinib-trametinib combination in patients with KRASm NSCLC Phase II: To determine the progression free survival of the lapatinib-trametinib combination compared…
This drug-drug interaction (DDI) study is being conducted to determine if there is a pharmacokinetic (PK) interaction between trametinib and the components of combination oral contraceptives (OCs), norethindrone (NE) and ethinyl estradiol (EE).…
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…
Primary: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…
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 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…
* Safety Run inTo determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part (part 3)* Biomarker cohortTo evaluate changes in the immune microenvironment and biomarker modulations upon treatment…