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Tyrosine Kinase Inhibitor

Pexidartinib for Giant Cell Tumor (PLX3397 Trial)

Phase 4
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and assessed every 6 months (treatment continuation) or every 3 months (treatment-free/re-treatment), up to approximately 24 months
Awards & highlights

PLX3397 Trial Summary

This trial will study whether it is safe to stop or restart treatment with the drug pexidartinib in people who have previously been treated for TGCT.

Eligible Conditions
  • Giant Cell Tumor

PLX3397 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and assessed every 6 months (treatment continuation) or every 3 months (treatment-free/re-treatment), up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and assessed every 6 months (treatment continuation) or every 3 months (treatment-free/re-treatment), up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Treatment-Free Participants at 12 Months
Proportion of Treatment-Free Participants at 24 Months
Secondary outcome measures
Change From Baseline in EQ-5D-5L during the Treatment-Free Period
Change From Baseline in PROMIS Physical Function Scale during the Treatment-Free Period
Number of Participants Who Reported TEAEs during the Re-treatment Period
+2 more

Side effects data

From 2021 Phase 3 trial • 120 Patients • NCT02371369
67%
Hair color changes
54%
Fatigue
39%
Aspartate aminotransferase increased
38%
Nausea
28%
Alanine aminotransferase increased
25%
Dysgeusia
23%
Arthralgia
21%
Diarrhea
20%
Vomiting
18%
Headache
18%
Periorbital edema
18%
Periorbital oedema
16%
Decreased appetite
16%
Abdominal pain
16%
Pruritis
15%
Blood alkaline phosphatase increased
15%
Hypertension
13%
Face oedema
13%
Face edema
13%
Edema peripheral
13%
Oedema peripheral
13%
Rash
11%
Blood lactate dehydrogenase increased
11%
Constipation
10%
Eye edema
10%
Asthenia
10%
Dizziness
10%
Eye oedema
10%
Dry mouth
10%
Rash maculo-papular
8%
Hypercholesterolemia
7%
Stomatitis
7%
Pain in extremity
7%
Nasopharyngitis
7%
Tumor pain
7%
Pyrexia
5%
Neutropenia
5%
Lacrimation increased
5%
Hypophosphataemia
5%
Anaemia
3%
Leukopenia
3%
Muscle spasms
3%
Palpitations
3%
Thrombocytopenia
2%
Hypoaesthesia
2%
Hepatotoxicity
2%
Tinnitus
2%
Hepatitis A
2%
Vertigo
2%
Migraine
2%
Hepatitis E
2%
Blood bilirubin increased
2%
Hepatic enzyme abnormal
2%
Liver disorder
2%
neck pain
2%
Myalgia
2%
Blood triglycerides increased
2%
Transaminases increased
2%
Liver function test abnormal
2%
Hepatoxicity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pexidartinib (Part 1)
Placebo (Part 1)
Pexidartinib (Parts 1 and 2)
Placebo (Part 1), Crossover Pexidartinib (Part 2)
All Pexidartinib Treated

PLX3397 Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment-Free/Re-Treatment CohortExperimental Treatment1 Intervention
Previously-treated participants with TGCT who discontinue pexidartinib treatment (Treatment-Free Period) and resume pexidartinib treatment at dose at completion of prior study (Re-Treatment Period).
Group II: Treatment Continuation CohortExperimental Treatment1 Intervention
Previously-treated participants with TGCT continuing their current dose of pexidartinib treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pexidartinib
2015
Completed Phase 4
~330

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
389 Previous Clinical Trials
409,741 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
415,079 Total Patients Enrolled
Clinical Team LeaderStudy DirectorDaiichi Sankyo
23 Previous Clinical Trials
4,378 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals of this experiment?

"Daiichi Sankyo, Inc., the trial sponsor has indicated that Proportion of Treatment-Free Participants at 12 Months will be used to assess the main objective over a Baseline up to 24 months after last participant enrolled in Cohort interval. As for secondary objectives, Percentage of Participants Achieving Tumor Response as assessed by Magnetic Resonance Imaging (MRI), Number of Participants Who Reported TEAEs during the Re-treatment Period and Change From Baseline in EQ-5D-5L during the Treatment-Free Period are all being evaluated. Specifically, TVS scores shall be classified according to RECIST criteria while patient responses"

Answered by AI

Has Pexidartinib been previously researched in any capacity?

"Pexidartinib was first examined in 2010 at City of Hope and since then, 17 studies have been completed. Of the 7 ongoing trials, a significant portion are being conducted in Saint Louis, Missouri."

Answered by AI

How many participants can potentially join this research endeavor?

"Unfortunately, this specific trial is not presently searching for patients. This medical study was visible on 10/20/2020 and the latest update occurred 4/29/2022. Fortunately, there are 15 clinical trials seeking participants with giant cells and 7 studies recruiting individuals taking Pexidartinib."

Answered by AI

Are qualified participants being accepted currently for this investigation?

"As per clinicaltrials.gov, this current medical trial is not seeking patients as of April 29th 2022. Initially posted on October 20 2020, it was last updated several months ago. Fortunately, there are 22 other trials that are actively looking for participants at present."

Answered by AI

What has been the primary application for Pexidartinib?

"Pexidartinib has been clinically proven to treat morbidity, fibrous histiocytoma of tendon sheath, and functional limitations."

Answered by AI

In what proportion of locations across the United States is this medical experiment being conducted?

"Currently, 6 clinical trial sites are enrolling patients for this medical study. These include Washington University in Saint Louis, Oregon Health & Science University in Portland and Honor Health in Scottsdale, with other hubs available across the country."

Answered by AI

Has Pexidartinib been granted authorization by the FDA?

"Our team at Power has assigned Pexidartinib a rating of 3, signifying its approval as a result of the Phase 4 trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
2020. "Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04526704.
~7 spots leftby Apr 2025
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