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) Therapy

Trial Profile

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) Therapy

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 May 2017

At a glance

  • Drugs Pexidartinib (Primary) ; PLX 9486 (Primary)
  • Indications Gastrointestinal stromal tumours; Solid tumours
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Plexxikon
  • Most Recent Events

    • 08 May 2017 Number of arms changed from 4 to 7,and patient number also changed from 92 to 200.
    • 01 May 2017 Planned End Date changed from 1 Sep 2018 to 1 Mar 2020.
    • 01 May 2017 Planned primary completion date changed from 1 Jun 2017 to 1 Aug 2019.
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