At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 109 enrolled
Drug / intervention
PLX4032drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX4032 in Patients With Solid Tumors
In Brief
A Phase 1 clinical trial evaluating PLX4032 for Malignant Melanoma and Colorectal Carcinoma. Completed, enrolled 109 participants across 7 sites in 2 countries.
Detailed Summary
The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma, Colorectal Carcinoma
CountriesAustralia, United States
CollaboratorsRoche Pharma AG
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedNov 2006
Primary CompletionJul 2015
Study CompletionFeb 2016
TodayJul 2026
First PostedNov 30, 2006
Enrollment StartNov 1, 2006
Primary CompletionJul 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 19.6 years ago
Interventions
PLX4032drug
Oral capsules administered BID