Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors

Phase 1

Terminated

• Conditions: Solid Tumor; Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations; Tenosynovial Giant Cell Tumor
• Interventions: Drug: PLX7486 TsOH

• Registration Number: NCT01804530
• Lead Sponsor: Plexxikon

Brief Summary

The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.

Detailed Description

Part 1. Open-label, sequential PLX7486 TsOH single-agent dose escalation in approximately 60 patients with solid tumors.

Study Timeline

• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-02
• Study First Posted: 2013-03-05
• Study Start: 2013-08
• Primary Completion: 2018-01-24
• Study Completion: 2018-01-24
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PLX7486-TsOH, Dose escalation and RP2D	PLX7486 TsOH	Part 1: Open-label, sequential PLX7486-TsOH single-agent dose escalation in approximately 60 patients with solid tumors.

Primary Outcome Measures

Name	Time	Method
Safety of PLX7486 as single agent as measured by adverse events and serious adverse events.	1 year
Area under the plasma concentration-time curve [AUC0-t, AUC0-inf]	1 year	Area under the plasma concentration-time curve \[AUC0-t, AUC0-inf\] will be used to assess the pharmacokinetic profile of PLX7486.
Peak concentration (Cmax)	1 year	Peak concentration (Cmax) will be used to assess the pharmacokinetic profile of PLX7486.
Time to peak concentration (Tmax)	1 year	Time to peak concentration (Tmax) will be used to assess the pharmacokinetic profile of PLX7486.
Half life (t1/2)	1 year	Half life (t1/2) will be used to assess the pharmacokinetic profile of PLX7486.
Terminal elimination rate constant (Kel)	1 year	Terminal elimination rate constant (Kel) will be used to assess the pharmacokinetic profile of PLX7486.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	1 year	Duration of response is defined as the number of days from the date of initial response (PR or better) to the date of first documented disease progression/relapse or death, whichever occurs first.
Progression-Free Survival (PFS)	6 month	Progression-free survival (PFS) is defined as the number of days from start of therapy to the date of documented disease progression/relapse, whichever occurs first.
Overall Response Rate (ORR)	1year
Overall Survival (OS)	1 year

Trial Locations

Locations (4)

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

John Hopkins Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States