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Tyrosine Kinase Inhibitor

PLX3397 + Sirolimus for Sarcoma (PLX3397 Trial)

Phase 1 & 2
Waitlist Available
Led By Gulam A. Manji, MD
Research Sponsored by Gulam Manji
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior treatment-related Adverse Events must be ≤ grade 1 (CTCAE v4.0), except alopecia, at time of initiating study drug
Disease site/type with pathologic confirmation of diagnosis at participating cancer site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

PLX3397 Trial Summary

This trial is testing a combination of drugs to see if they can effectively treat cancer while also being tolerable for patients. The first part of the trial establishes what dose is safe for patients, and the second part measures how well the combination works at that dose.

Who is the study for?
Adults with advanced, unresectable sarcoma or malignant peripheral nerve sheath tumors (MPNSTs) who have had up to three prior treatments. Participants must be able to undergo tumor biopsies, not be pregnant or breastfeeding, and agree to use effective contraception. They should have a performance status allowing daily activity and measurable disease.Check my eligibility
What is being tested?
The trial is testing the combination of PLX3397 and Sirolimus for treating certain types of sarcomas that cannot be surgically removed. The first phase determines the highest dose patients can tolerate without severe side effects; the second phase checks if this dose can stop cancer growth.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, vomiting, diarrhea, increased risk of infection due to immune system suppression by Sirolimus, potential liver issues or heart problems. Specific reactions depend on individual health conditions.

PLX3397 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My side effects from previous treatments are mild, except for hair loss.
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My cancer type has been confirmed with a biopsy at a participating site.
Select...
My sarcoma cannot be removed with surgery and is advanced.
Select...
My cancer is an advanced MPNST that cannot be surgically removed.
Select...
My cancer cannot be removed with surgery.
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.

PLX3397 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) - Phase 1
Progression free survival (PFS) rate - Phase 2
Secondary outcome measures
Overall survival rate

Side effects data

From 2012 Phase 2 trial • 20 Patients • NCT01217229
40%
Fatigue
40%
Hair colour changes
40%
Hair depigmentation
30%
Anaemia
30%
Thrombocytopenia
25%
Dyspnea
25%
Dyspnoea
25%
Rash
25%
Blood lactate dehydrogenase increased
20%
Pyrexia
15%
Cough
15%
Decreased appetite
10%
Chills
10%
Dizziness
10%
Headache
10%
Back pain
10%
Productive cough
10%
Diarrhoea
10%
Nausea
10%
Vomiting
10%
Aspartate aminotransferase increased
5%
Ear pain
5%
Eye swelling
5%
Clostridial infection
5%
Constipation
5%
Face odema
5%
Leukopenia
5%
Neutropenia
5%
Syncope
5%
Eyelid oedema
5%
Abdominal pain
5%
Abdominal distension
5%
Asthenia
5%
Muscular weakness
5%
Dysgeusia
5%
Lethargy
5%
Neuropathy peripheral
5%
Tremor
5%
Anxiety
5%
Hallucination
5%
Insomnia
5%
Menstruation irregular
5%
Erythema multiforme
5%
Pruritus
5%
Hyperglycaemia
5%
Hyperkalaemia
5%
Joint swelling
5%
Haemoptysis
5%
Pleuritic pain
5%
Dry skin
5%
Squamous cell carcinoma
5%
Balance disorder
5%
Skin exfoliation
5%
Skin hypopigmentation
5%
Lung infection
5%
Gastrooesophageal reflux disease
5%
Herpes zoster
5%
Nasopharyngitis
5%
Pneumonia
5%
Alanine aminotransferase increased
5%
Blood alkaline phosphatase
5%
Neutrophil count decreased
5%
Swelling face
100%
80%
60%
40%
20%
0%
Study treatment Arm
PLX3397

PLX3397 Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2: PLX3397 and SirolimusExperimental Treatment2 Interventions
Cohort 2 (Phase 2): Subjects with unresectable or metastatic Malignant Peripheral Nerve Sheath Tumors (MPNSTs) will take PLX3397 and Sirolimus at the recommended Phase 2 dose (RP2D).
Group II: Phase 1: PLX3397 and SirolimusExperimental Treatment2 Interventions
Cohort 1 (Phase 1): Subjects with unresectable or metastatic sarcoma will take orally PLX3397 (600 - 1000mg) in combination with Sirolimus (2-6mg) daily .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved
Pexidartinib
FDA approved

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
388 Previous Clinical Trials
409,524 Total Patients Enrolled
3 Trials studying Sarcoma
Gulam ManjiLead Sponsor
4 Previous Clinical Trials
120 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
415,122 Total Patients Enrolled
3 Trials studying Sarcoma

Media Library

PLX3397 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02584647 — Phase 1 & 2
Sarcoma Research Study Groups: Phase 2: PLX3397 and Sirolimus, Phase 1: PLX3397 and Sirolimus
Sarcoma Clinical Trial 2023: PLX3397 Highlights & Side Effects. Trial Name: NCT02584647 — Phase 1 & 2
PLX3397 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02584647 — Phase 1 & 2

Frequently Asked Questions

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

What is the highest participation rate for this medical experiment?

"This clinical trial requires 43 patients that meet the criteria of eligibility. Those able to take part can do so at Washington University in St. Louis, Missouri or University of Iowa in Iowa City, Iowa."

Answered by AI

To what extent has PLX3397 been tested in scientific investigations?

"At present, there are 131 studies that focus on PLX3397. Of those trials, 14 have entered the third phase of clinical testing. Although much of this research is conducted in Cincinnati Ohio, 1148 other locations around the world are involved in these investigations."

Answered by AI

How widely dispersed is the oversight of this trial?

"This research endeavor is recruiting volunteers from multiple medical institutions, such as Washington University in St. Louis (Missouri), the University of Iowa (Iowa City) and Columbia University (New york)."

Answered by AI

What has the primary application of PLX3397 been in medical practice?

"Rejection of organ transplants, particularly those involving the liver, can often be treated with PLX3397. This medication has also been seen to ease functional limitation in kidneys and lungs."

Answered by AI

Is there presently an opportunity to participate in this research study?

"This clinical trial is still open for recruitment, as per the medical data on clinicaltrials.gov. Initially posted on November 4th 2015, this study was last updated a mere two days ago in November 7th 2022."

Answered by AI
Recent research and studies
~5 spots leftby Mar 2025