Trial · NCT01734512

PNOC 001: Phase II Study of Everolimus for Recurrent or Progressive Low-grade Gliomas in Children

NCT01734512, Phase 2, Completed, University of California, San Francisco; results first posted 2021-02-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PNOC 001: Phase II Study of Everolimus for Recurrent or Progressive Low-grade Gliomas in Children. Trials, record NCT01734512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01734512

On this page

Trial

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

Title: PNOC 001: Phase II Study of Everolimus for Recurrent or Progressive Low-grade Gliomas in Children
NCT number: NCT01734512
Status: Completed
Phases: Phase 2
Enrollment: 65 participants, actual
Lead sponsor: University of California, San Francisco
Conditions: Pediatric Recurrent Progressive Low-grade Gliomas, Pediatric Progressive Low-grade Gliomas
Interventions: Everolimus
First posted: 2012-11-27
Last updated: 2025-09-09
Results first posted: 2021-02-18

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Progression Free Survival at 6 Months	Up to 6 months	Response was be determined by bi-dimensional diameters. RECIST criteria will be collected and used for secondary evaluation. Patients will have brain MRI scans with and without gadolinium performed prior to therapy, after every second course in the first year, after every third course in the second year, and at the End of Study visit (if not done within prior 3 months). Spine MRIs should be performed prior to therapy and at the same time points as standard brain MRIs if clinically indicated.
Secondary	Proportion of Participants With Objective Response	Up to 6 months	The proportion of participants who demonstrated a complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1 Criteria where Complete Response (CR) is defined as the complete disappearance of all known disease for \>=8 weeks. Complete response is dated from time all lesions have disappeared on a stable or decreasing dose of corticosteroids. A Partial Response (PR) is a reduction of at least 50% in the size of all measurable tumor as quantitated by sum of the products of the largest diameters (SLD) of measurable lesions and maintained for \>=8 weeks on a stable or decreasing dose of corticosteroids. Partial response is dated from the time of first observation. Overall response also takes into account the response in both the target and non-target lesion, and the appearance of new lesions, where applicable and depend on the achievement of both measurement and confirmation criteria.
Secondary	Median Progression Free Survival in Recurrent Pediatric Low-grade Glioma (LGGs)	Up to 5 years	Progression free survival will be calculated from date of first treatment to the date of first observation of progressive disease, non-reversible neurological progression or increasing steroid requirements (applies to stable disease only), death due to any cause, or early discontinuation of treatment
Secondary	Median Overall Survival From Time of Diagnosis	Up to 5 years	Overall survival in participants with recurrent pediatric low-grade glioma (LGGs) will be calculated from date of original diagnoses to death using Kaplan Meier method. Median time to death and 95% confidence interval will be reported.
Secondary	Median Overall Survival From Time of Enrollment	Up to 5 years	Overall survival in participants with recurrent pediatric low-grade glioma (LGGs) will be calculated from date of study registration to death using Kaplan Meier method. Median time to death and 95% confidence interval will be reported.

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	Percentage of Participants With Progression Free Survival at 6 Months	Up to 6 months		percentage	NUMBER
SECONDARY	Proportion of Participants With Objective Response	Up to 6 months		proportion of participants	NUMBER
SECONDARY	Median Progression Free Survival in Recurrent Pediatric Low-grade Glioma (LGGs)	Up to 5 years		days	MEDIAN
SECONDARY	Median Overall Survival From Time of Diagnosis	Up to 5 years		days	MEDIAN
SECONDARY	Median Overall Survival From Time of Enrollment	Up to 5 years	Less than 50% of the participants died at the time study data collection ended, so a median survival time could not be calculated due to the insufficient number of events.	days	MEDIAN

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
Percentage of Participants With Progression Free Survival at 6 Months	Everolimus	67	95% Confidence Interval 54 to 77	percentage
Proportion of Participants With Objective Response	Everolimus	0.05		proportion of participants
Median Progression Free Survival in Recurrent Pediatric Low-grade Glioma (LGGs)	Everolimus	365	95% Confidence Interval 225 to 765	days
Median Overall Survival From Time of Diagnosis	Everolimus	NA	95% Confidence Interval NA to NA	days
Median Overall Survival From Time of Enrollment	Everolimus	NA	95% Confidence Interval NA to NA	days

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Everolimus	65
Overall Study	COMPLETED	Everolimus	65
Overall Study	NOT COMPLETED	Everolimus	0

Source ClinicalTrials.gov

Adverse events69

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	Events
other	Cholesterol high	Investigations	Everolimus	34	65	63
other	Aspartate aminotransferase increased	Investigations	Everolimus	30	65	62
other	Alanine aminotransferase increased	Investigations	Everolimus	26	65	60
other	Neutrophil count decreased	Investigations	Everolimus	19	65	41
other	Lymphocyte count decreased	Investigations	Everolimus	15	65	25
other	White blood cell decreased	Investigations	Everolimus	15	65	49
other	Platelet count decreased	Investigations	Everolimus	14	65	23
other	Investigations - Other	Investigations	Everolimus	11	65	27
other	Weight loss	Investigations	Everolimus	6	65	8
other	Alkaline phosphatase increased	Investigations	Everolimus	6	65	7

1 to 10 of 69Source ClinicalTrials.gov

See all 69 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Everolimus	9	65
Total, other adverse events	Everolimus	62	65
Total, serious adverse events	Everolimus	20	65

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37978951	DERIVED

Source PubMed

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/NCT01734512

GET https://conductscience.org/api/trials/v1/NCT01734512/events?page=2

API reference For AI assistants