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

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ClinicalTrials.gov Identifier: NCT00290550
Recruitment Status : Terminated
First Posted : February 13, 2006
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290550


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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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    Key Record Dates
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