PLX3397 : A Phase 4, Multicenter Study to Evaluate Discontinuation and Re-Treatment in Subjects With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

FourPhase Four

18+Age Over 18

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Systemic therapy,Treatment | Urinary systemGerm cell tumour

Trial Overview Read MoreRead more

This phase IV trial is comparing the outcomes of continuing or discontinuing pexidartinib treatment in patients that have previously received treatment for tenosynovial giant cell tumours.
 

This trial is treating patients with Tenosynovial Giant Cell Tumour.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase 4, Multicenter Study to Evaluate Discontinuation and Re-Treatment in Subjects With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib

Commercial Sponsor

Daiichi Sankyo, Inc.

Summary

To be eligible for this trial, potential participants must be enrolled in one of the following studies: Currently enrolled and on pexidartinib treatment in one of the following studies: Study PLX108-10 (ENLIVEN), Study PLX108-01, Study PL3397-A-A103 or Study PL3397-A-U126. Investigators and participants will be given the option (at screening) to either continue pexidartinib treatment (Treatment Continuation Cohort) or discontinue treatment with the possibility of re-initiating pexidartinib treatment (Treatment-Free/Re-Treatment Cohort). Previously-treated participants in the 'Treatment Continuation Cohort' will continue their current dose of pexidartinib treatment (at an oral dose of 200 mg, administered twice daily on an empty stomach).

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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