A Phase IIA Study of MK0457 in Patients With Cancer of the Lung (0457-006)

Phase 2TerminatedNCT00290550

Merck Sharp & Dohme LLC22 enrolled

Overview

This is a study to evaluate the effectiveness of an investigational drug in patients with cancer of the lung.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

MK0457DRUG

IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are at least 18 years of age with cancer of the lung and who have had either no previous treatment or 1 previous treatment for advanced cancer of the lung. Certain other treatments may also be allowed (prior cytotoxic chemotherapy in the adjuvant setting) Exclusion Criteria: * Patients who have had treatment with any investigational therapy within the past 30 days are not eligible. * Patients who have had a disease or medical condition that is not controlled will not be eligible. * Patients who are pregnant or breastfeeding are not eligible.

Outcomes

Primary Outcomes

Efficacy of MK0457 as a 5 day infusion as measured by radiological exams at baseline and after every other cycle of treatment. After 3 post-treatment radiological assessments, response will be measured after every third cycle.

Time frame: 5 Days

Secondary Outcomes

Safety and tolerability as measured by duration, intensity (grade) and time of onset of toxicity.

Time frame: 5 Days

Data from ClinicalTrials.gov

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