12 results
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment.
To assess the anti-tumor activity of LGX818/MEK162 in combination with third targeted agents after progression on LGX818/MEK162 combination therapy.
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…
The objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium plus olodaterol fixed dose combination compared with the individual components tiotropium and olodaterol (delivered by…
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 / 5 µg ; 5 / 5 µg) with tiotropium (5 µg), olodaterol (5 µg) and placebo on lung-hyperinflation and endurance time…
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 +…
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 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…
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…
Primary:* Phase 1b:o Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of binimetinib administered in combination with nivolumabo Determine the MTD and RP2D of binimetinib administered in combination with nivolumab plus…
The main purpose of this study is to assess investigate the effect of encorafenib and binimetinib (the study drugs) on the activity of other common drugs and the effect of modafinil on the activity of encorafenib. The study will also look at the…
Part A1(KIN-2787 Monotherapy Escalation):Determine safety and tolerability of PO administration of Kin-2787 including DLT in participants with BRAFmutation-positive advanced or metastatic solid tumors or melanoma harboring NRAS-mutation. Identify…