Title: A Phase 1b and 2a Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX9486 as a Single Agent and in Combination With PLX3397 or Sunitinib (Sutent®) in Patients With Advanced Solid Tumors and Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumor (GIST) Who Have Been Previously Treated With Imatinib Mesylate/KIT-Directed Tyrosine Kinase Inhibitor (TKI) Therapy1
Principal Investigators: None listed
Description: For this non-randomized, open-label phase 1b/2 study, researchers are evaluating the safety and efficacy of PLX9486, a TKI of c-Kit, in combination with pexidartinib (PLX3397) and sunitinib among patients with GIST. As KIT is often mutated in GISTs, this combination is predicted to halt cancer cell proliferation.
This study has 7 arms: part 1, the dose escalation arm for determining the maximum tolerated dose of PLX9486, and 6 arms of part 2, in which patients will be stratified by several variables.
The primary outcomes are safety, overall response rate, progression-free survival, overall survival, and pharmacokinetics of PLX9486; secondary outcomes include duration of response.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02401815.
Status: This study is open and recruiting patients as of October 26, 2017.
This study is sponsored by Plexxikon.
- Clinicaltrials.gov. PLX9486 as a single agent and in combination with PLX3397 or PLX9486 with sunitinib in patients with advanced solid tumors. NCT02401815. https://clinicaltrials.gov/ct2/show/NCT02401815. Accessed October 26, 2017.