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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00863122 |
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Date of registration:
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13/03/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Concentration and Activity of Lapatinib in Vestibular Schwannomas
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Scientific title:
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Exploration and Estimation of Intratumoral Concentration and Activity of Lapatinib in Vivo in Vestibular Schwannomas |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00863122 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Jaishri O Blakeley, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Meet diagnostic criteria for NF2 including presence of bilateral VS or idiopathic VS
without evidence of genetic syndrome.
- VS surgery determined clinically necessary by the treating physician and scheduled
within 4 weeks.
- Normal cardiac left ventricular ejection fraction (LVEF) by multiple-gated acquisition
(MUGA) scan or transthoracic echocardiogram.
- Karnofsky performance status 60% (i.e. the patient must be able to care for
himself/herself with occasional help from others).
- Must have the following hematologic, renal and liver function: Absolute neutrophil
count = 1,000/mm³ (unsupported); platelet count = 75,000/mm³ (unsupported); hemoglobin
= 8 g/dL (transfusion support allowed); Creatinine = 1.5 times upper limit of normal
(ULN) OR glomerular filtration rate = 70 ml/min; Bilirubin = 1.5 times ULN; ALT = 2.5
times ULN.
- Be able to provide written informed consent.
- Any neurologic deficits must be stable for = 1 week.
- Be able to swallow tablets.
- Subjects 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.
- Suspend the use of P450 inducing or P450 suppressing agents for a minimum of 10 days
prior to starting lapatinib.
Exclusion Criteria:
- Serious concurrent infection or medical illness, which would jeopardize the ability of
the patient to receive the treatment outlined in this protocol with reasonable safety.
- Pregnant or breast-feeding.
- Receiving concurrent therapy for their tumor (i.e. chemotherapeutics or
investigational agents, radiation or immunotherapy) within 4 weeks of the first dose
of the study drug.
- Concurrent or prior malignancy, other than curatively treated carcinoma-in-situ or
basal cell carcinoma of the skin. Subjects who have been free of disease (any prior
malignancy) for five years are eligible for this study.
- 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) within 10 days prior to starting lapatinib.
- Significant gastrointestinal disorder(s)(e.g., Crohn's disease, ulcerative colitis,
extensive gastric resection).
- Neurologic deficits that are rapidly progressing.
- Known cardiac disease (either arrhythmia or congestive heart failure) requiring
treatment.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Vestibular Schwannoma
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Neurofibromatosis 2
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NF2
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Acoustic Neuroma
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Auditory Tumor
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Intervention(s)
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Drug: lapatinib
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Primary Outcome(s)
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To Assess Whether Lapatinib Can Reach a Minimum Tumor Concentration Level of >3uM in VS After Oral Dosing.
[Time Frame: one year]
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Median Steady-state Lapatinib Plasma Concentrations at the Time of Surgical Resection
[Time Frame: At time of surgery, 10-13 days from starting drug.]
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Secondary Outcome(s)
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Assess Markers of Tumor Proliferation and Cell Death in VS After Exposure to Lapatinib.
[Time Frame: at time of surgery]
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Assess the Level of ErbB2 Phosphorylation in VS.
[Time Frame: at time of surgery]
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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.
[Time Frame: at time of surgery]
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Explore the Difference in the Concentration of Lapatinib Achieved in NF2-related Versus Idiopathic VS.
[Time Frame: one year]
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Secondary ID(s)
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J0867
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NA_00020841
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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