The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.
Part 1. Open-label, sequential PLX7486 TsOH single-agent dose escalation in approximately 60 patients with solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
PLX7486 TsOH capsules, 50mg
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Safety of PLX7486 as single agent as measured by adverse events and serious adverse events.
Time frame: 1 year
Area under the plasma concentration-time curve [AUC0-t, AUC0-inf]
Area under the plasma concentration-time curve \[AUC0-t, AUC0-inf\] will be used to assess the pharmacokinetic profile of PLX7486.
Time frame: 1 year
Peak concentration (Cmax)
Peak concentration (Cmax) will be used to assess the pharmacokinetic profile of PLX7486.
Time frame: 1 year
Time to peak concentration (Tmax)
Time to peak concentration (Tmax) will be used to assess the pharmacokinetic profile of PLX7486.
Time frame: 1 year
Half life (t1/2)
Half life (t1/2) will be used to assess the pharmacokinetic profile of PLX7486.
Time frame: 1 year
Terminal elimination rate constant (Kel)
Terminal elimination rate constant (Kel) will be used to assess the pharmacokinetic profile of PLX7486.
Time frame: 1 year
Duration of response (DOR)
Duration of response is defined as the number of days from the date of initial response (PR or better) to the date of first documented disease progression/relapse or death, whichever occurs first.
Time frame: 1 year
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the number of days from start of therapy to the date of documented disease progression/relapse, whichever occurs first.
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Time frame: 6 month
Overall Response Rate (ORR)
Time frame: 1year
Overall Survival (OS)
Time frame: 1 year