Clinical Trial Search

Primary: Area Under the Plasma Concentration-time Curve (AUC) From Time of Administration to Last Observed Plasma Concentration (AUClast) for Binimetinib — 1786; 1723 h*ng/mL

Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 52; 12 Participants

Primary: Accuracy — 0.76; 0.73; 0.80 Cohen's Kappa

Primary: Overall Change From Baseline in TNSS at Visits 3, 4 and 5 — 3.9; 4.1; 5.2 TNSS score (0-12) — p=0.0085

Primary: Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) — 4 Participants

Primary: Maximum Concentration (Cmax) — 29.9; 62.4; 70.5 Cmax ng/ml

Primary: The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs) — 0; 2; 2…

Primary: Accuracy of HM-MRI — 0.55 proportion of participants — p=0.02

Primary: Number of Adverse Events — 12; 2; 8; 4 events

Primary: Safety and Tolerability of Belnacasan — 11; 10; 0; 0 Number of AEs and SAEs

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 6; 7; 4; 9 Participants

Primary: Program Sustainability Assessment Tool — 2.1 score on a scale

Primary: Number of Patients With DLTs in the MTD Evaluation Period — 0; 0; 2 Participants

Primary: Patient Health Questionnaire (PHQ-9) — 12.6; 15.2 score on a scale

Primary: Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy — 243 Participants