Trial · NCT00863122
Concentration and Activity of Lapatinib in Vestibular Schwannomas
NCT00863122, Early phase 1, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2018-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Concentration and Activity of Lapatinib in Vestibular Schwannomas. Trials, record NCT00863122. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00863122
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Concentration and Activity of Lapatinib in Vestibular Schwannomas
- NCT number
- NCT00863122
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Vestibular Schwannoma, NF2, Neurofibromatosis 2, Acoustic Neuroma, Auditory Tumor
- Interventions
- lapatinib
- First posted
- 2009-03-17
- Last updated
- 2021-01-12
- Results first posted
- 2018-11-26
- Limitations and caveats
A total of 10 tissue and 11 plasma samples donated by participants receiving lapatinib and 2 tissue samples from control participants were lost from analysis due to freezer failure denaturing the samples. This substantially reduced the sample size.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Steady-state Lapatinib Plasma Concentrations at the Time of Surgical Resection | At time of surgery, 10-13 days from starting drug. | Steady-state plasma concentrations of lapatinib (ng/mL) at time of surgery, 10-13 days from starting drug. |
| Primary | To Assess Whether Lapatinib Can Reach a Minimum Tumor Concentration Level of >3uM in VS After Oral Dosing. | one year | Count of tissue samples with lapatinib concentration \>3uM |
| Secondary | Assess the Level of ErbB2 Phosphorylation in VS. | at time of surgery | Assessed number of samples with high expression of phospho-ErbB2 in tissue at time of surgery |
| Secondary | Assess Markers of Tumor Proliferation and Cell Death in VS After Exposure to Lapatinib. | At time of surgery | |
| Secondary | Explore the Difference in the Concentration of Lapatinib Achieved in NF2-related Versus Idiopathic VS. | one year | A comparison in the median lapatinib concentration (ng/g) in vestibular schwannomas associated with neurofibromatosis type 2 and sporadic vestibular schwannomas |
| Secondary | Perform NF2 Gene Mutation Analysis Via Exon Scanning and MLPA as Well as Protein Expression in All VS and Explore Differences Between Sporadic and NF2 Related VS. | at time of surgery | Due to the sample sizes, a comparison between sporadic and NF2-related vestibular schwannomas could not be made. Instead we report the mutational status. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Steady-state Lapatinib Plasma Concentrations at the Time of Surgical Resection | At time of surgery, 10-13 days from starting drug. | In the lapatinib group, 10 tissue and plasma samples were lost from analysis due to a freezer failure during a natural disaster denaturing the samples. 1 blood sample was contaminated, but tissue was available. Control group did not get any drug. A total of 8 participants of 19 given drug had data for analysis. | ng/mL | MEDIAN |
| PRIMARY | To Assess Whether Lapatinib Can Reach a Minimum Tumor Concentration Level of >3uM in VS After Oral Dosing. | one year | In the lapatinib group, 10 tissue and plasma samples were lost from analysis due to a freezer failure during a natural disaster denaturing the samples. Nine samples were available for tissue concentration assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Assess the Level of ErbB2 Phosphorylation in VS. | at time of surgery | 10 lapatinib participants and 3 control participants did not have adequate tissue for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Assess Markers of Tumor Proliferation and Cell Death in VS After Exposure to Lapatinib. | At time of surgery | The experiment to assess this outcome measure failed and no interpretable data could be collected. | ||
| SECONDARY | Explore the Difference in the Concentration of Lapatinib Achieved in NF2-related Versus Idiopathic VS. | one year | Of the nine participants in the lapatinib who had tumor available for analysis, four had a vestibular schwnannoma associated with a diagnosis of neurofibromatosis type 2 (NF2); five had sporadic vestibular schwannomas. | ng/g | MEDIAN |
| SECONDARY | Perform NF2 Gene Mutation Analysis Via Exon Scanning and MLPA as Well as Protein Expression in All VS and Explore Differences Between Sporadic and NF2 Related VS. | at time of surgery | 6 of the 7 participants had sporadic VS; 1 of 7 had NF2-associated VS. As such, we were unable to explore differences between the groups. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Steady-state Lapatinib Plasma Concentrations at the Time of Surgical Resection | Lapatinib | 3149 | Full Range 786 to 5830 | ng/mL | |
| To Assess Whether Lapatinib Can Reach a Minimum Tumor Concentration Level of >3uM in VS After Oral Dosing. | Lapatinib | 7 | Participants | ||
| Assess the Level of ErbB2 Phosphorylation in VS. | Lapatinib | 5 | Participants | ||
| Assess the Level of ErbB2 Phosphorylation in VS. | Control | 2 | Participants | ||
| Explore the Difference in the Concentration of Lapatinib Achieved in NF2-related Versus Idiopathic VS. | NF2 Associated VS | 8367 | Full Range 314 to 17821 | ng/g | |
| Explore the Difference in the Concentration of Lapatinib Achieved in NF2-related Versus Idiopathic VS. | Sporadic VS | 4502 | Full Range 1737 to 11712 | ng/g | |
| Perform NF2 Gene Mutation Analysis Via Exon Scanning and MLPA as Well as Protein Expression in All VS and Explore Differences Between Sporadic and NF2 Related VS. | Participants With Tissue Available for Gene Mutation Analysis | Hemizygous deletion in NF2 gene | 4 | Participants | |
| Perform NF2 Gene Mutation Analysis Via Exon Scanning and MLPA as Well as Protein Expression in All VS and Explore Differences Between Sporadic and NF2 Related VS. | Participants With Tissue Available for Gene Mutation Analysis | Homozygous deletion in NF2 gene | 1 | Participants | |
| Perform NF2 Gene Mutation Analysis Via Exon Scanning and MLPA as Well as Protein Expression in All VS and Explore Differences Between Sporadic and NF2 Related VS. | Participants With Tissue Available for Gene Mutation Analysis | No deletion in NF2 gene | 2 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lapatinib | 19 | |
| Overall Study | STARTED | Control | 7 | |
| Overall Study | COMPLETED | Lapatinib | 19 | |
| Overall Study | COMPLETED | Control | 7 | |
| Overall Study | NOT COMPLETED | Lapatinib | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | 6 | 19 | 6 |
| other | Rash | Skin and subcutaneous tissue disorders | Control | 0 | 0 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Lapatinib | 7 | 19 | 7 |
| other | Diarrhea | Gastrointestinal disorders | Control | 0 | 0 | 0 |
| other | Fatigue | General disorders | Lapatinib | 4 | 19 | 4 |
| other | Fatigue | General disorders | Control | 0 | 0 | 0 |
| other | Nausea | Gastrointestinal disorders | Lapatinib | 4 | 19 | 4 |
| other | Nausea | Gastrointestinal disorders | Control | 0 | 0 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Lapatinib | 2 | 19 | 2 |
| other | Acne | Skin and subcutaneous tissue disorders | Control | 0 | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lapatinib | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Lapatinib | 12 | 19 |
| Total, other adverse events | Control | 0 | 0 |
| Total, serious adverse events | Lapatinib | 0 | 19 |
| Total, serious adverse events | Control | 0 | 0 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lapatinib vs Control: Assess the Level of ErbB2 Phosphorylation in VS. |
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.
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/NCT00863122
GET https://conductscience.org/api/trials/v1/NCT00863122/registered