Trial · NCT04917042

Tazemetostat in Malignant Peripheral Nerve Sheath Tumors

NCT04917042, Phase 2, Active not recruiting, University of Florida; results first posted 2026-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Tazemetostat in Malignant Peripheral Nerve Sheath Tumors. Trials, record NCT04917042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04917042

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Tazemetostat in Malignant Peripheral Nerve Sheath Tumors
NCT number: NCT04917042
Status: Active not recruiting
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: University of Florida
Conditions: Peripheral Nerve Sheath Tumor
Interventions: Tazemetostat
First posted: 2021-06-08
Last updated: 2026-06-04
Results first posted: 2026-02-04

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate	143 days	Assess the objective response rate, defined as the proportion of subjects who achieve either a complete response or partial response based on radiographic evaluation of treatment response via RECIST1.1. A complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
Secondary	Progression Free Survival	143 days	Determine the progression free survival, defined as the length of time from the date of start of treatment to the date of disease progression per RECIST 1.1 criteria. Per RECIST 1.1 criteria, disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Secondary	Time to Progression	143 days	Determine the time to progression, defined as the length of time from the start of treatment until disease progression by RECIST 1.1 criteria. Per RECIST 1.1 criteria, disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Secondary	Clinical Benefit	143 days	Determine the clinical benefit using the Numbered Pain Rating Scale. For this scale, the subject rates their pain on a scale of 0 to 10. Zero means "no pain," and 10 means "the worst possible pain." For each patient, the mean pain rating scale score was computed by adding all the non-missing scores the patient had and then taking the average.
Secondary	Clinical Benefit Rate	143 days	Assess the clinical benefit rate, defined as the proportion of subjects with complete or partial response or stable disease (by RECIST 1.1 criteria) lasting at least 4 months. Per RECiST 1.1 criteria, a complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. A partial response is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Stable disease is defined as having neither sufficient shrinkage for a partial response nor sufficient increase for progressive disease, taking as reference the smallest sum diameters while on study.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate	143 days	One participant was not evaluable for this outcome measure because a RECIST response was not obtained after baseline.	percentage of participants	NUMBER
SECONDARY	Progression Free Survival	143 days	One participant was not evaluable for this outcome measure because a RECIST response was not obtained after baseline.	months	MEDIAN
SECONDARY	Time to Progression	143 days	One participant was not evaluable for this outcome measure because a RECIST response was not obtained after baseline.	months	MEDIAN
SECONDARY	Clinical Benefit	143 days	One participant was not included as they were not evaluable.	score on a scale	MEAN
SECONDARY	Clinical Benefit Rate	143 days	One participant was not evaluable for this outcome measure because a RECIST response was not obtained after baseline.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Objective Response Rate	Tazemetostat	0		percentage of participants
Progression Free Survival	Tazemetostat	1.9	95% Confidence Interval 1.2 to NA	months
Time to Progression	Tazemetostat	1.9	95% Confidence Interval 1.2 to NA	months
Clinical Benefit	Tazemetostat	3.4	Standard Deviation 2.7	score on a scale
Clinical Benefit Rate	Tazemetostat	0		percentage of participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tazemetostat	10
Overall Study	COMPLETED	Tazemetostat	9
Overall Study	NOT COMPLETED	Tazemetostat	1

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anal fissure	Gastrointestinal disorders	Tazemetostat	1	10
other	Anemia	Blood and lymphatic system disorders	Tazemetostat	2	10
other	Anorexia	Metabolism and nutrition disorders	Tazemetostat	1	10
other	Anxiety	Psychiatric disorders	Tazemetostat	1	10
other	Arthralgia	Musculoskeletal and connective tissue disorders	Tazemetostat	1	10
other	Blood bilirubin increased	Investigations	Tazemetostat	1	10
other	Chest pain	Musculoskeletal and connective tissue disorders	Tazemetostat	1	10
other	Cholesterol high	Investigations	Tazemetostat	1	10
other	Constipation	Gastrointestinal disorders	Tazemetostat	2	10
other	Cough	Respiratory, thoracic and mediastinal disorders	Tazemetostat	2	10

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tazemetostat	9	10
Total, other adverse events	Tazemetostat	10	10
Total, serious adverse events	Tazemetostat	4	10

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04917042

GET https://conductscience.org/api/trials/v1/NCT04917042/events?page=2

API reference For AI assistants