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

NCT00050336 | Terminated Phase 3

• 1 other identifier: P01901
• Study Type: interventional
• Target: 702
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Stage 3b or 4 (metastatic) non-small cell lung cancer

Interventions

Lonafarnib (SARASAR) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

lonafarnib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2002
• First Posted: December 5, 2002
• Study Start: December 1, 2002
• Primary Completion: February 1, 2004
• Study Completion: March 1, 2004
• Last Updated: August 27, 2015

Record last verified: 2015-08