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

Carcinoma, Non-small-cell Lung Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00050336
• Other study ID #: P01901
• Status: Terminated
• Phase: Phase 3
• First received: December 4, 2002
• Last updated: August 26, 2015
• Start date: December 2002
• Est. completion date: March 2004

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 702
• Est. completion date: March 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lonafarnib (SARASAR)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.