Trial · NCT00939523
Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy
NCT00939523, Phase 2, Completed, Cedars-Sinai Medical Center; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy. Trials, record NCT00939523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00939523
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy
- NCT number
- NCT00939523
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Cedars-Sinai Medical Center
- Conditions
- Pituitary Adenomas, Prolactinomas
- Interventions
- Lapatinib
- First posted
- 2009-07-15
- Last updated
- 2020-01-22
- Results first posted
- 2020-01-13
- Limitations and caveats
- For one of the secondary outcomes, the ErbB receptor expression, only 3 subjects had tumor specimens available to immunostain. Therefore, only results on 3 subjects were reported for this outcome.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Tumor Volume | baseline and at 6 months | Tumor volume will be assessed on MRI at 6 months on therapy and compared to baseline MRI. |
| Primary | Number of Participants With 50% Reduction in Prolactin Levels | every month, up to 6 months | 50% reduction in prolactin level measured monthly on 6 months therapy compared to baseline level. |
| Secondary | % Change in Prolactin From Baseline to Study End | Baseline and at 6 months | Percent prolactin change from start of lapatinib to end of study participant participation |
| Secondary | ErbB Receptor Expression | at 6 months | Mean percent positive expression of EGFR and ErbB2 will be tested on pathologic tumor specimens from subjects treated with lapatinib |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Tumor Volume | baseline and at 6 months | 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. | Percent volume | MEDIAN |
| PRIMARY | Number of Participants With 50% Reduction in Prolactin Levels | every month, up to 6 months | There were 6 prolactinomas and 3 nonfunctioning tumors in this trial. Prolactin results are only reported for the prolactinomas. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | % Change in Prolactin From Baseline to Study End | Baseline and at 6 months | Prolactin results only reported on the 6 prolactinomas in the trial and not for the nonfunctioning tumors. | percent change in prolactin | MEDIAN |
| SECONDARY | ErbB Receptor Expression | at 6 months | 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. | percent positive expression | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Tumor Volume | Lapatinib | 10 | Full Range -41.4 to 318 | Percent volume | |
| Number of Participants With 50% Reduction in Prolactin Levels | Lapatinib | 1 | Participants | ||
| % Change in Prolactin From Baseline to Study End | Lapatinib | -7.0 | Full Range -78.5 to 103.0 | percent change in prolactin | |
| ErbB Receptor Expression | Lapatinib | 0 | Standard Deviation 0 | percent positive expression |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lapatinib | 9 | |
| Overall Study | COMPLETED | Lapatinib | 6 | |
| Overall Study | NOT COMPLETED | Lapatinib | 3 |
Source ClinicalTrials.gov
Adverse events5
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 | Lapatinib | 5 | 9 | |
| other | Diarrhea | Gastrointestinal disorders | Lapatinib | 2 | 9 | |
| other | Bradycardia | Cardiac disorders | Lapatinib | 3 | 9 | |
| other | Transaminitis | Hepatobiliary disorders | Lapatinib | 2 | 9 | |
| serious | Transaminitis | Hepatobiliary disorders | Lapatinib | 1 | 9 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lapatinib | 0 | 9 |
| Total, other adverse events | Lapatinib | 8 | 9 |
| Total, serious adverse events | Lapatinib | 1 | 9 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT00939523
GET https://conductscience.org/api/trials/v1/NCT00939523/registered