PLX121-01
18 evidence topics · 3 sources
Objective
Location and study date
Study design
Summary
The monotherapy and sunitinib-combination cohorts used nonrandomized 3+3 dose escalation.
Blinding and dose-escalation design
Eligibility criteria
Treatment
Summary
The early-trial recommended phase 2 dose was PLX9486 1000 mg daily, combined with sunitinib 25 or 37.5 mg daily in continuous 28-day cycles.
Recommended phase 2 dose
| Drug | Daily dose, mg |
|---|---|
| PLX9486 | “1000” |
Study outcomes
Rationale for using maximum tolerated dose as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Combination efficacy cohort
Description of analysis sets
Summary
Sample sizes reflected clinical considerations. Response intervals used exact binomial methods, and survival analyses used Kaplan-Meier methods.
Time-to-event analysis method
Results
Participant disposition
Summary
Three monotherapy participants were reenrolled in the extension, producing a safety population of 18 without increasing unique enrollment.
Combination-extension safety population
| Population | Participants |
|---|---|
| Including reenrolled participants | “18” |
Baseline characteristics
Efficacy results
PLX9486 plus sunitinib phase 1b/2a: efficacy
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Combination dose-limiting toxicity and commonly reported adverse events
Study limitations
Summary
The combination efficacy cohort included 15 PLX9486-naive participants. Nonrandomized treatment assignment, small sample size, and disease heterogeneity limit comparative interpretation.