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

Primary Purpose

Carcinoma, Non-small-cell Lung, Metastases, Neoplasm

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lonafarnib (SARASAR)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-small-cell Lung focused on measuring Stage 3b or 4 (metastatic) non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2002
    Last Updated
    August 26, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00050336
    Brief Title
    Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    February 2004 (Actual)
    Study Completion Date
    March 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Non-small-cell Lung, Metastases, Neoplasm
    Keywords
    Stage 3b or 4 (metastatic) non-small cell lung cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    702 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Lonafarnib (SARASAR)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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