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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

702 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-03-31

Brief Summary

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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

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Conditions

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Carcinoma, Non-small-cell Lung Metastases, Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Lonafarnib (SARASAR)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P01901

Identifier Type: -

Identifier Source: org_study_id

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