Trial · NCT00973739
Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
NCT00973739, Phase 2, Completed, NYU Langone Health; results first posted 2016-03-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors. Trials, record NCT00973739. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00973739
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
- NCT number
- NCT00973739
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Neurofibromatosis 2, Vestibular Schwannoma
- Interventions
- Lapatinib
- First posted
- 2009-09-09
- Last updated
- 2016-03-22
- Results first posted
- 2016-03-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimated Volumetric Progression Free Survival at 12 Months | Every three months for one year | Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of volumetric progression. PFS was analyzed using the Kaplan-Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression. Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan-Meier curves. |
| Secondary | Estimated Volumetric Progression Free Survival for Hearing at 12 Months | Every three months for one year | Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of hearing progression. PFS was analyzed using the Kaplan-Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression. Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan-Meier curves. |
| Secondary | Participants Experiencing Grades 1 or 2 Toxicities (CTCAE) | Baseline through one year | Toxicity was assessed throughout the study, up to one year. |
| Secondary | Participants Experiencing Grade 3 Toxicities (CTCAE) | Baseline through one year | Toxicity was assessed throughout the study, up to one year. |
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 | Estimated Volumetric Progression Free Survival at 12 Months | Every three months for one year | This analysis is based on the 17 evaluable patients. | Liklihood of PFS at 12 months | MEAN |
| SECONDARY | Estimated Volumetric Progression Free Survival for Hearing at 12 Months | Every three months for one year | This analysis is based on the 17 evaluable patients. | Liklihood of PFS at 12 months | MEAN |
| SECONDARY | Participants Experiencing Grades 1 or 2 Toxicities (CTCAE) | Baseline through one year | participants | NUMBER | |
| SECONDARY | Participants Experiencing Grade 3 Toxicities (CTCAE) | Baseline through one year | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Estimated Volumetric Progression Free Survival at 12 Months | Lapatinib | 70.6 | 95% Confidence Interval 43.1 to 86.6 | Liklihood of PFS at 12 months | |
| Estimated Volumetric Progression Free Survival for Hearing at 12 Months | Lapatinib | 88.9 | 95% Confidence Interval 43.3 to 98.4 | Liklihood of PFS at 12 months | |
| Participants Experiencing Grades 1 or 2 Toxicities (CTCAE) | Lapatinib | 21 | participants | ||
| Participants Experiencing Grade 3 Toxicities (CTCAE) | Lapatinib | 1 | participants |
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 | 21 | |
| Overall Study | COMPLETED | Lapatinib | 17 | |
| Overall Study | NOT COMPLETED | Lapatinib | 4 |
Source ClinicalTrials.gov
Adverse events40
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 | Vasovagal syncope | Nervous system disorders | Lapatinib | 1 | 21 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Lapatinib | 5 | 21 | 5 |
| other | Anorexia | Metabolism and nutrition disorders | Lapatinib | 2 | 21 | 2 |
| other | Anxiety | Psychiatric disorders | Lapatinib | 2 | 21 | 2 |
| other | Ataxia | Nervous system disorders | Lapatinib | 1 | 21 | 1 |
| other | Constipation | Gastrointestinal disorders | Lapatinib | 1 | 21 | 1 |
| other | Decreased bicarbonate | Metabolism and nutrition disorders | Lapatinib | 5 | 21 | 5 |
| other | Dermatology/Skin (Other) | Skin and subcutaneous tissue disorders | Lapatinib | 19 | 21 | 19 |
| other | Diarrhea | Gastrointestinal disorders | Lapatinib | 15 | 21 | 15 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Lapatinib | 1 | 21 | 1 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lapatinib | ||
| Total, other adverse events | Lapatinib | 21 | 21 |
| Total, serious adverse events | Lapatinib | 0 | 21 |
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 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/NCT00973739
GET https://conductscience.org/api/trials/v1/NCT00973739/events?page=2