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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00973739
Date of registration: 03/09/2009
Prospective Registration: No
Primary sponsor: New York University School of Medicine
Public title: Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Scientific title: Phase II Study of Lapatinib in Children and Adults With Neurofibromatosis Type 2(NF2) and NF2-related Tumors
Date of first enrolment: September 2009
Target sample size: 21
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00973739
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Matthias A Karajannis, MD, MS
Address: 
Telephone:
Email:
Affiliation:  NYU School of Medicine
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients must be at least 4 years of age.

2. Patients must meet diagnostic criteria for NF2 and at least one volumetrically
measured NF2-related brain or spinal tumor with radiographic evidence of progression
over the past 12 months, designated as the primary target OR volumetrically measurable
VS with ipsilateral progressive hearing loss over the past 12 months, designated as
the primary target tumor.

3. Significant hearing loss criteria for enrollment.

4. Karnofsky (PS) OR Lansky 50-100% (>16 years of age)

5. Absolute neutrophil count = 1,000/mm3 g/dL

6. Hemoglobin = 8 g/dL

7. Creatinine = 1.5 times upper limit of normal (ULN) OR corrected glomerular filtration
rate = 70 ml/min

8. Bilirubin = 1.5 times ULN

9. ALT = 2.5 times ULN

10. Fully recovered from acute toxic effects of any prior chemotherapy, biological
modifiers or radiotherapy.

11. Steroids are allowed for progressive symptoms but patient must be on a stable dose for
at least 1 week prior to study entry.

12. Any neurologic deficits must be stable for = 1 week.

13. Patients with the potential for pregnancy or impregnating their partner must agree to
follow acceptable birth control methods to avoid conception. Women of childbearing
potential must have a negative pregnancy test. The anti-proliferative activity of this
experimental drug may be harmful to the developing fetus.

14. Normal cardiac left ventricular ejection fraction (LVEF) by transthoracic
echocardiogram.

15. Able to provide written informed consent (or consent by parent/legal guardian for
minors)

Exclusion Criteria:

1. Patients with serious concurrent infection or medical illness.

2. Neurological deficits that are rapidly progressing.

3. Patients who are pregnant or breast-feeding.

4. Anti-tumor therapy within 4 weeks prior to enrollment.

5. Radiation therapy within 2 months prior to enrollment.

6. Prior therapy with agents targeting EGFR or ErbB2.

7. Any surgery within 4 weeks prior to enrollment.

8. Significant gastrointestinal disorder(s)

9. Known cardiac disease

10. Patients with a concurrent or prior malignancy are ineligible unless they are patients
with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin.
Patients who have been free of disease (any prior malignancy) for more than five years
are eligible for this study.

11. Patients cannot have received cytochrome P450-inducing anticonvulsants (EIADs; e.g.,
phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) or similar agents
(e.g., rifampin) or P450-inhibiting agents (Ketoconazole, Itraconazole,
Clarithromycin, Atazanavir, Indinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir,
Telithromycin, Voriconazole)



Age minimum: 4 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Vestibular Schwannoma
Neurofibromatosis 2
Intervention(s)
Drug: Lapatinib
Primary Outcome(s)
Estimated Volumetric Progression Free Survival at 12 Months [Time Frame: Every three months for one year]
Secondary Outcome(s)
Estimated Volumetric Progression Free Survival for Hearing at 12 Months [Time Frame: Every three months for one year]
Participants Experiencing Grades 1 or 2 Toxicities (CTCAE) [Time Frame: Baseline through one year]
Participants Experiencing Grade 3 Toxicities (CTCAE) [Time Frame: Baseline through one year]
Secondary ID(s)
09-0328
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
GlaxoSmithKline
Ethics review
Results
Results available: Yes
Date Posted: 22/03/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00973739
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