Clinical Trial: A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Giant Cell Tumor

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX73086 as a Single Agent in Subjects With Advanced Solid Tumors and in Subjects With Locally Advanced or Refractory Tenosy

Brief Summary: The purpose of this research study is to evaluate safety, pharmacokinetics and preliminary efficacy of the investigational drug PLX73086 in subjects with solid tumors including subjects with locally advanced or refractory tenosynovial giant cell tumor (TGCT).

Detailed Summary:
Sponsor: Plexxikon

Current Primary Outcome:

  • Safety of PLX73086, as measured by adverse events and serious adverse events [Part 1 and Part 2 of research study] [ Time Frame: 1 year ]
  • Area under the concentration-time curve (AUC) of PLX73086 [Part 1 of research study] [ Time Frame: 1 year ]
  • Maximum observed concentration (Cmax) of PLX73086 [Part 1 of research study] [ Time Frame: 1 year ]
  • Time to peak concentration (Tmax) of PLX73086 [Part 1 of research study] [ Time Frame: 1 year ]
  • Half life (t1/2) of PLX73086 [Part 1 of research study] [ Time Frame: 1 year ]
  • Overall response rate [Part 2 of research study] [ Time Frame: 1 year ]
    Overall response rate (ORR) as defined by the proportion of patients who achieve a complete response (CR) or partial response (PR) by RECIST 1.1


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy of PLX73086 measured by overall response rate (ORR) [Part 1 of research study] [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Plexxikon

Dates:
Date Received: January 29, 2016
Date Started: February 2016
Date Completion: October 2019
Last Updated: April 25, 2017
Last Verified: April 2017