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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00050336
Other study ID # P01901
Secondary ID
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


Intervention

Drug:
Lonafarnib (SARASAR)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.
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