Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)
This study has been terminated.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: December 4, 2002
Last updated: November 4, 2013
Last verified: November 2013
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.
Carcinoma, Non-small-cell Lung
Drug: Lonafarnib (SARASAR)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
||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:
| Study Completion Date:
| Primary Completion Date:
||March 2004 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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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No Contacts or Locations Provided
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 4, 2002
||November 4, 2013
||United States: Food and Drug Administration
Keywords provided by Merck Sharp & Dohme Corp.:
Stage 3b or 4 (metastatic) non-small cell lung cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action