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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: MK0457	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	22 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase IIA Study Evaluating the Efficacy of MK0457 as a 5-Day Continuous Infusion in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Start Date :	June 2006
Actual Primary Completion Date :	May 2007
Actual Study Completion Date :	May 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
1; MK-0457	Drug: MK0457; IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. Safety and tolerability as measured by duration, intensity (grade) and time of onset of toxicity. [ Time Frame: 5 Days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00290550 History of Changes
Other Study ID Numbers:	0457-006; 2006_008
First Posted:	February 13, 2006
Last Update Posted:	July 27, 2015
Last Verified:	July 2015

Keywords provided by Merck Sharp & Dohme Corp.:

Advanced Non-Small Cell Lung Cancer; NSCLC

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms	Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases