Trial · NCT00045110

Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma

NCT00045110, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-07-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma. Trials, record NCT00045110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00045110

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Trial

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

Title: Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
NCT number: NCT00045110
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 136 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Grade III Meningioma, Recurrent Adult Brain Tumor
Interventions: erlotinib hydrochloride, laboratory biomarker analysis, pharmacological study
First posted: 2003-01-27
Last updated: 2017-08-17
Results first posted: 2017-07-13

Source ClinicalTrials.gov

Registered outcomes18

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

List	Outcome	Time frame	Description
Primary	Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I	28 days	DLT Definition: any grade 3 thrombocytopenia and grade 4 anemia and neutropenia; any non-hematologic grade 3 toxicity; failure to recover from toxicities to be eligible for re-treatment with erlotinib within 2 weeks of the last dose of erlotinib.
Primary	Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts	cycle 1 - 28 days	standard 3+3 dose escalation design 3 patients in each dose level, observed for 28 days before enrollment to next level. if none of the patients experienced DLT dose escalated, if 1 of 3 experienced DLT 3 more enrolled at that level, if none of the 3 additional pts had DLT escalate to next level, if one or more of the additional pts experienced DLT, the MTD was exceeded and 3 more patients were treated at the next lower dose (if only 3 pts treated at the lower dose). The MTD is the dose at which 0/3 or 1/6 patients have experienced a DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.
Primary	6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)	6 months	Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Secondary	Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1	1 year	CTCAE
Secondary	1 Year Survival - Phase II Newly Diagnosed GBM Post RT	At 1 year	12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT
Secondary	Overall Survival Newly Diagnosed GBM Post RT	2 years	Overall Survival defined as Time from Start of treatment to time of death due to any cause
Secondary	Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II	At 1 year	Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): \>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Secondary	Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II	Up to 1 year	Summarized by descriptive statistics.
Secondary	Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -	baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1.	plasma concentrations relative to erlotiniab administration and sample time and dose level
Secondary	Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -	baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5	plasma concentrations relative to erlotiniab administration and sample time and dose level

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I	28 days	Patients were eligible if they had recurrent disease or if they were newly diagnosed post RT and did NOT have tumor progression (nonprogression glioblastoma) on Enzyme-inducing Antiepileptic Drugs	dose limiting toxicities	NUMBER
PRIMARY	Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts	cycle 1 - 28 days	Cohorts/dose levels: 150mg; 200mg; 275mg; 400mg; 525mg; 650mg; 775mg patients on Enzyme-inducing Antiepileptic Drugs	mg	NUMBER
PRIMARY	6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)	6 months	38 Glioblastoma, 15 anaplastic gliomas not receiving Enzyme-inducing Antiepileptic Drugs	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1	1 year	During Cycle 1 only grade 3 severity; patients on Enzyme-inducing Antiepileptic Drugs	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	1 Year Survival - Phase II Newly Diagnosed GBM Post RT	At 1 year	not receiving Enzyme-inducing Antiepileptic Drugs; stable glioblastoma after RT	% of participants	NUMBER
SECONDARY	Overall Survival Newly Diagnosed GBM Post RT	2 years	not receiving Enzyme-inducing Antiepileptic Drugs, glioblastoma stable after RT	months	MEDIAN
SECONDARY	Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II	At 1 year	recurrent malignant gliomas - anaplastic and glioblastoma	participants	NUMBER
SECONDARY	Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II	Up to 1 year	drug related events grade 3-5 CTCAE. 5 patients were not evaluable for response/toxicity.	percent of participants	NUMBER
SECONDARY	Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -	baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1.	tmax=time of peak plasma concentration	h	MEAN
SECONDARY	Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -	baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5	Cp=peak plasma concentration;	ng/mL	MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group52

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

Outcome	Group	Category	Value	Units
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I	Phase 1 Dose Escalation	Dose 150mg (Rash)	1	dose limiting toxicities
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I	Phase 1 Dose Escalation	Dose 200mg	0	dose limiting toxicities
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I	Phase 1 Dose Escalation	Dose 275mg	0	dose limiting toxicities
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I	Phase 1 Dose Escalation	Dose 400mg	0	dose limiting toxicities
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I	Phase 1 Dose Escalation	Dose 525mg	0	dose limiting toxicities
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I	Phase 1 Dose Escalation	Dose 650mg (DVT/PE)	1	dose limiting toxicities
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I	Phase 1 Dose Escalation	Dose 775mg (Rash [2])	2	dose limiting toxicities
Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts	Phase 1 Dose Escalation		650	mg
6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)	Phase 2 Recurrent Malignant Gliomas	Recurrent GBM	2	Participants
6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)	Phase 2 Recurrent Malignant Gliomas	Recurrent Anaplastic Glioma	14	Participants

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow63

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

Period	Milestone	Group	Participants
100mg Phase 1 Dose Escalalation	STARTED	Phase 1 Dose Escalation	6
100mg Phase 1 Dose Escalalation	STARTED	Phase 2 - Recurrent Malignant Glioma	59
100mg Phase 1 Dose Escalalation	STARTED	Phase 2 - Newly Diagnosed GBM Post RT	45
100mg Phase 1 Dose Escalalation	COMPLETED	Phase 1 Dose Escalation	6
100mg Phase 1 Dose Escalalation	COMPLETED	Phase 2 - Recurrent Malignant Glioma	53
100mg Phase 1 Dose Escalalation	COMPLETED	Phase 2 - Newly Diagnosed GBM Post RT	43
100mg Phase 1 Dose Escalalation	NOT COMPLETED	Phase 1 Dose Escalation	0
100mg Phase 1 Dose Escalalation	NOT COMPLETED	Phase 2 - Recurrent Malignant Glioma	6
100mg Phase 1 Dose Escalalation	NOT COMPLETED	Phase 2 - Newly Diagnosed GBM Post RT	2
200mg Phase 1 Dose Escalation	STARTED	Phase 1 Dose Escalation	4

1 to 10 of 63Source ClinicalTrials.gov

See all 63 participant flow

Adverse events14

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	rash	Skin and subcutaneous tissue disorders	Phase 1 Dose Escalation	19	32	19
other	rash	Skin and subcutaneous tissue disorders	Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm	11	99	11
other	granulocytopenia	Investigations	Phase 1 Dose Escalation	2	32	2
other	granulocytopenia	Investigations	Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm	0	99	0
other	diarrhea	Gastrointestinal disorders	Phase 1 Dose Escalation	9	32	9
other	diarrhea	Gastrointestinal disorders	Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm	2	99	2
other	fatigue	General disorders	Phase 1 Dose Escalation	5	32	5
other	fatigue	General disorders	Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm	3	99	3
other	nausea	Gastrointestinal disorders	Phase 1 Dose Escalation	3	32	3
other	nausea	Gastrointestinal disorders	Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm	0	99	0

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1 Dose Escalation
Total, all-cause mortality	Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm
Total, other adverse events	Phase 1 Dose Escalation	27	32
Total, other adverse events	Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm	11	99
Total, serious adverse events	Phase 1 Dose Escalation	0	32
Total, serious adverse events	Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm	2	99

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20150371	BACKGROUND

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01CA062399	NABTC Central Operation Grant (UCSF Project Leader)	PRADOS, MICHAEL D	UNIVERSITY OF CALIFORNIA, SAN FRANCISCO	NATIONAL CANCER INSTITUTE	1994 to 2008

Source NIH RePORTER

Trial comparisons1

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

Comparison
Phase 1 Dose Escalation vs Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm: serious adverse events

Source Trial comparisons

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.

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