Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Monotherapy: Area Under the Concentration-Time Curve From Time Zero to Time of Last Concentration (AUC 0-t) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment

  Measured over: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8

• Monotherapy: Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-Inf) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment

  Measured over: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8

• Monotherapy: Maximum Plasma Concentration (Cmax) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment

  Measured over: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8

• Combination Therapy (Arms: A and B): Overall Response Rate (ORR) as Assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  Measured over: Up to 25 months

• Combination Therapy (Arm C): Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Measured over: From start of study drug administration up to survival follow-up (up to 25 months)

Changes Tremor has spotted