Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)

Phase 3

Terminated

• Conditions: Carcinoma, Non-small-cell Lung; Metastases, Neoplasm

• Registration Number: NCT00050336
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2002-12-04
• Study First Submitted QC: 2002-12-04
• Study First Posted: 2002-12-05
• Primary Completion: 2004-02
• Study Completion: 2004-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 702

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL