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

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ClinicalTrials.gov Identifier: NCT00050336
Recruitment Status : Terminated
First Posted : December 5, 2002
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small-cell Lung Metastases, Neoplasm Drug: Lonafarnib (SARASAR) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 702 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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 Start Date : December 2002
Actual Primary Completion Date : February 2004
Actual Study Completion Date : March 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00050336    
Other Study ID Numbers: P01901
First Posted: December 5, 2002    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Stage 3b or 4 (metastatic) non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Lonafarnib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action