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

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00290550

First received: February 9, 2006

Last updated: July 24, 2015

Last verified: July 2015

History of Changes

Purpose

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

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: MK0457	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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


Enrollment:	22
Study Start Date:	June 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 MK-0457	Drug: MK0457 IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290550

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00290550 History of Changes
Other Study ID Numbers:	0457-006 2006_008
Study First Received:	February 9, 2006
Last Updated:	July 24, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016

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