Carcinoma, Non-small-cell Lung Clinical Trial
Official title:
A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin vs. Placebo in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
Verified date | August 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine the overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in combination with paclitaxel and carboplatin.
Status | Terminated |
Enrollment | 702 |
Est. completion date | March 2004 |
Est. primary completion date | February 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female - 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 chemotherapy for any stage of NSCLC - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Merck Sharp & Dohme Corp. |
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