Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)
NCT ID: NCT00050336
Last Updated: 2015-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
702 participants
INTERVENTIONAL
2002-12-31
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Lonafarnib (SARASAR)
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol.
* Age greater than or equal to 18 years old
* ECOG performance status of 0 to 1
* Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified.
* Meets protocol requirements for specified laboratory values
* Written informed consent
* Appropriate use of effective contraception if of childbearing potential
* Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease
Exclusion Criteria
* Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy
* Concurrent treatment or treatment within the last 2 years for any other malignancy
* Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication)
* Medical conditions that would interfere with taking oral medications
* Patients with bone metastases as the only site of disease
* Pregnant or nursing women
* Known HIV positivity or AIDS-related illness
* Patients with significant QTc prolongation at baseline
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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P01901
Identifier Type: -
Identifier Source: org_study_id
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