26 results
Primary: Longterm safety and tolerability of AMG 145.Secondary: Longterm efficacy of AMG 145.
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with heterozygous…
Primary Objective: To characterize the safety and tolerability of long-term administration ofAMG 145 among subjects with severe familial hypercholesterolemia
Primary objective: Phase Ib (see study design): Maximum Tolerated Dose(s) and/or Recommended Phase II Dose (RP2D) of LEE011 and MEK162 in combination. Phase II (see study design): Assess the anti-tumor activity of the LEE011 and MEK162 combination…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives:…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives: Safety…
Primary ObjectivePart A: To characterize the effect of 12 weeks of subcutaneous (SC) AMG 145 on percentchange from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with homozygousfamilial hypercholesterolemiaPart B: To evaluate…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with heterozygous familial hypercholesterolemia.Secondary…
To determine whether treatment with MEK162 prolongs PFS as compared to dacarbazine in patients with previously untreated, advanced unresectable, or metastatic NRAS mutation-positive melanoma who are previously untreated or who have progressed on or…
To assess the anti-tumor activity of LGX818/MEK162 in combination with third targeted agents after progression on LGX818/MEK162 combination therapy.
Safety Lead-inIn patients with BRAF V600E mutant (BRAFV600E) metastatic colorectal cancer (mCRC):Primary: • Assess the safety/tolerability of the combination of encorafenib + binimetinib + cetuximabSecondary:• Assess the activity of encorafenib +…
Encorafenib/binimetinb combination therapy can possibly reduce tumor size and thus making surgical treatment less comprehensive. In addition, the treatment can potentially improve recurrence-free survival, overall survival, and distant metastases-…
To characterize the safety and tolerability.1. To describe the available RFS data by treatment arm.2. To describe the available DMFS data by treatment arm.3. To describe-reported health-related quality of life (HRQoL) bytreatment arm.
To determine whether treatment with LGX818 plus MEK162 prolongs progression free survival (PFS) compared with vemurafenib, and/or whether treatment with LGX818 prolongs PFS compared with vemurafenib in patients with BRAF V600 mutant locally advanced…
Main objective:To evaluate change over time in executive function, as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory (SWM) strategy index of executive function, in subjects receiving statin…
Primary Objective: Phase I dose escalationThe main objective of the phase I part is to determine safety and the recommended phase II dose (RP2D) of the triple combination.Phase IIThe main objective of the phase II part is to determine efficacy of…
- To monitor the safety and tolerability of binimetinib- To monitor the safety and tolerability of encorafenib
Primary ObjectiveSafety Lead-in* Evaluate the safety of a high-dose regimen of encorafenib + binimetinib combination therapy in patients with BRAFV600-mutant melanoma who have asymptomatic brain metastasisPhase 2If the high-dose regimen is…
Sub-study APhase 1b:To assess the DLT rate and estimate the MTD of sasanlimab in combination with encorafenib and binimetinib to determine the RP2D for the combination. Phase 2:To assess the durable ORR of sasanlimab in combination with encorafenib…
Primary:- To evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the confirmed overall response rate (cORR) by local radiologist/investigator assessment in adult subjects with previously…