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Trial record 38 of 109 for:    "Schwannoma"

Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors

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ClinicalTrials.gov Identifier: NCT00973739
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
New York University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neurofibromatosis 2
Vestibular Schwannoma
Intervention Drug: Lapatinib
Enrollment 21
Recruitment Details Twenty-one patients were enrolled between October 2009 and March 2011 at New York University Medical Center.
Pre-assignment Details  
Arm/Group Title Lapatinib
Hide Arm/Group Description Lapatinib will be administered
Period Title: Overall Study
Started 21
Completed 17
Not Completed 4
Arm/Group Title Lapatinib
Hide Arm/Group Description Lapatinib will be administered
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
4
  19.0%
Between 18 and 65 years
17
  81.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
28  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
8
  38.1%
Male
13
  61.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Estimated Volumetric Progression Free Survival at 12 Months
Hide Description

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.

Time Frame Every three months for one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis is based on the 17 evaluable patients.
Arm/Group Title Lapatinib
Hide Arm/Group Description:

Lapatinib PO dosed according to age:

Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily

Adults (18 years of age or older): 1,500 mg PO once daily

Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment.

Overall Number of Participants Analyzed 17
Mean (95% Confidence Interval)
Unit of Measure: Liklihood of PFS at 12 months
70.6
(43.1 to 86.6)
2.Secondary Outcome
Title Estimated Volumetric Progression Free Survival for Hearing at 12 Months
Hide Description

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.

Time Frame Every three months for one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis is based on the 17 evaluable patients.
Arm/Group Title Lapatinib
Hide Arm/Group Description:

Lapatinib PO dosed according to age:

Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily

Adults (18 years of age or older): 1,500 mg PO once daily

Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment.

Overall Number of Participants Analyzed 17
Mean (95% Confidence Interval)
Unit of Measure: Liklihood of PFS at 12 months
88.9
(43.3 to 98.4)
3.Secondary Outcome
Title Participants Experiencing Grades 1 or 2 Toxicities (CTCAE)
Hide Description Toxicity was assessed throughout the study, up to one year.
Time Frame Baseline through one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib
Hide Arm/Group Description:

Lapatinib PO dosed according to age:

Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily

Adults (18 years of age or older): 1,500 mg PO once daily

Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment.

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
21
4.Secondary Outcome
Title Participants Experiencing Grade 3 Toxicities (CTCAE)
Hide Description Toxicity was assessed throughout the study, up to one year.
Time Frame Baseline through one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib
Hide Arm/Group Description:

Lapatinib PO dosed according to age:

Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily

Adults (18 years of age or older): 1,500 mg PO once daily

Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment.

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lapatinib
Hide Arm/Group Description Lapatinib will be administered
All-Cause Mortality
Lapatinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib
Affected / at Risk (%) # Events
Total   0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lapatinib
Affected / at Risk (%) # Events
Total   21/21 (100.00%)    
Blood and lymphatic system disorders   
Anemia  5/21 (23.81%)  5
Lymphopenia  5/21 (23.81%)  5
Cardiac disorders   
Pericardial effusion on echocardiogram  1/21 (4.76%)  1
Possible ectopic atrial bradycardia on EKG  1/21 (4.76%)  1
Premature supraventricular complexes on EKG  1/21 (4.76%)  1
Sinus Bradycardia  2/21 (9.52%)  2
Eye disorders   
Keratitis  2/21 (9.52%)  2
Gastrointestinal disorders   
Constipation  1/21 (4.76%)  1
Diarrhea  15/21 (71.43%)  15
heartburn  1/21 (4.76%)  1
Hemorrhage - rectum (stools)  1/21 (4.76%)  1
Nausea  4/21 (19.05%)  4
Vomiting  3/21 (14.29%)  3
General disorders   
Fatigue  9/21 (42.86%)  9
Fever  1/21 (4.76%)  1
Pain-Other  8/21 (38.10%)  8
Investigations   
Hyperbilirubinemia  2/21 (9.52%)  2
Increased ALT  4/21 (19.05%)  4
Increased AST  7/21 (33.33%)  7
Increased PTT  1/21 (4.76%)  1
Metabolism and nutrition disorders   
Anorexia  2/21 (9.52%)  2
Decreased bicarbonate  5/21 (23.81%)  5
Hyperglycemia  9/21 (42.86%)  9
Hyperkalemia  2/21 (9.52%)  2
Hypernatremia  2/21 (9.52%)  2
Hypocalcemia  2/21 (9.52%)  2
Hypoglycemia  3/21 (14.29%)  3
Hypokalemia  5/21 (23.81%)  5
Hypophosphatemia  4/21 (19.05%)  4
Nervous system disorders   
Vasovagal syncope  1/21 (4.76%)  1
Ataxia  1/21 (4.76%)  1
Memory Impairment  2/21 (9.52%)  2
Numbness L-S area  1/21 (4.76%)  1
Psychiatric disorders   
Anxiety  2/21 (9.52%)  2
Insomnia  2/21 (9.52%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/21 (4.76%)  1
Epistaxis  4/21 (19.05%)  4
Skin and subcutaneous tissue disorders   
Dermatology/Skin (Other)  19/21 (90.48%)  19
Stomatitis (oral cavity ulceration)  1/21 (4.76%)  1
Vascular disorders   
Hypertension  1/21 (4.76%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Matthias Karajannis, MD
Organization: New York University Langone Medical Center
Phone: 212-263-8400
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00973739     History of Changes
Other Study ID Numbers: 09-0328
First Submitted: September 3, 2009
First Posted: September 9, 2009
Results First Submitted: June 27, 2013
Results First Posted: March 22, 2016
Last Update Posted: March 22, 2016