A Study of JZP815 Oral Capsules
Phase 1
332
about 5.5 years
18+
14 sites in CO, FL, IL +6
What this study is about
This trial is testing a treatment called JZP815 in adults with advanced or metastatic solid tumors that have changes in the MAPK pathway. The goal is to learn about its safety, how it works in the body (pharmacokinetics), and if it can kill cancer cells (antitumor activity).
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take JZP815
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Change From Baseline in Absolute Neutrophil Count (Part A and B), Change From Baseline in Alanine Aminotransferase (Part A and B), Change From Baseline in Aspartate Aminotransferase (Part A and B), Change From Baseline in Blood Pressure (Part A and B), Change From Baseline in Creatinine (Part A and B), Change From Baseline in Heart Rate (Part A and B), Change From Baseline in Hematocrit (Part A and B), Change From Baseline in Hemoglobin (Part A and B)
Secondary: Objective Response Rate (as Defined by RECIST v1.1) (Part A), Overall Survival (Part B), Pharmacokinetic Parameter Accumulation Ratio of JZP815 and its Metabolites (Part A), Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP815 and its Metabolites (Part A), Pharmacokinetic Parameter Apparent Volume of Distribution During Terminal Phase (Vz/F) of JZP815 (Part A), Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP815 and its Metabolites (Part A), Pharmacokinetic Parameter Clearance (CL/F) of JZP815 (Part A), Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP815 and its Metabolites (Part A)
Oncology