NCT00939523 · STUDY IN CONTEXT

Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Tumor volume will be assessed on MRI at 6 months on therapy and compared to baseline MRI.

Note: 1 subject was withdrawn after 6 weeks of lapatinib therapy and therefore not included in analysis. A 2nd subject was not included in this analysis as the drug was given on compassionate basis to prevent recurrence of her tumor. She had a negative baseline MRI and maintained a negative MRI at study end.

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primary · POSTED

50% reduction in prolactin level measured monthly on 6 months therapy compared to baseline level.

There were 6 prolactinomas and 3 nonfunctioning tumors in this trial. Prolactin results are only reported for the prolactinomas.

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secondary · POSTED

Percent prolactin change from start of lapatinib to end of study participant participation

Prolactin results only reported on the 6 prolactinomas in the trial and not for the nonfunctioning tumors.

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secondary · POSTED

Mean percent positive expression of EGFR and ErbB2 will be tested on pathologic tumor specimens from subjects treated with lapatinib

Of the subjects who participated in the trial, only 3 had available tumor tissue to immunostain. Therefore, results could not be reported on the other subjects.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-adenoma
nct id: NCT00939523
trial label: Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT00939523
outcome key
om-0000
source section id
NCT00939523-om-0000
source outcome index
0
endpoint
Change in Tumor Volume
endpoint definition
Tumor volume will be assessed on MRI at 6 months on therapy and compared to baseline MRI.
time origin
baseline and at 6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Note: 1 subject was withdrawn after 6 weeks of lapatinib therapy and therefore not included in analysis. A 2nd subject was not included in this analysis as the drug was given on compassionate basis to prevent recurrence of her tumor. She had a negative baseline MRI and maintained a negative MRI at study end.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT00939523
outcome key
om-0001
source section id
NCT00939523-om-0001
source outcome index
1
endpoint
Number of Participants With 50% Reduction in Prolactin Levels
endpoint definition
50% reduction in prolactin level measured monthly on 6 months therapy compared to baseline level.
time origin
every month, up to 6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
There were 6 prolactinomas and 3 nonfunctioning tumors in this trial. Prolactin results are only reported for the prolactinomas.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT00939523
outcome key
om-0002
source section id
NCT00939523-om-0002
source outcome index
2
endpoint
% Change in Prolactin From Baseline to Study End
endpoint definition
Percent prolactin change from start of lapatinib to end of study participant participation
time origin
Baseline and at 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Prolactin results only reported on the 6 prolactinomas in the trial and not for the nonfunctioning tumors.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT00939523
outcome key
om-0003
source section id
NCT00939523-om-0003
source outcome index
3
endpoint
ErbB Receptor Expression
endpoint definition
Mean percent positive expression of EGFR and ErbB2 will be tested on pathologic tumor specimens from subjects treated with lapatinib
time origin
at 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Of the subjects who participated in the trial, only 3 had available tumor tissue to immunostain. Therefore, results could not be reported on the other subjects.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT00939523
outcome key
om-0000
arm key
OG000
arm label
Lapatinib
regimen
All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study. Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939523-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT00939523
outcome key
om-0001
arm key
OG000
arm label
Lapatinib
regimen
All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study. Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939523-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT00939523
outcome key
om-0002
arm key
OG000
arm label
Lapatinib
regimen
All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study. Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939523-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT00939523
outcome key
om-0003
arm key
OG000
arm label
Lapatinib
regimen
All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study. Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939523-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-adenoma
nct id
NCT00939523
harm key
EG000
source section id
NCT00939523-ae
event group key
EG000
event group label
Lapatinib
serious affected
1
serious at risk
9
other affected
8
other at risk
9
frequency threshold
5
collection period
Adverse event data were collected over 6 months
event definition
Prior to initiating therapy, patients were assessed with monthly echocardiogram,ECG, physical examinations, chemistry and hematology panels. Adverse events were graded by the NCI-CTC. Subjects with toxicity equal to Grade 3 on the NCI-CTC will have their dose held and resumed at a fifty percent dose reduction when the toxicity has resolved. Those subjects with toxicity equal to Grade 4 were discontinued on the study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice