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

Arm | Intervention/treatment |
---|---|
1
MK-0457
|
Drug: MK0457
IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days
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- 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 ]
- Safety and tolerability as measured by duration, intensity (grade) and time of onset of toxicity. [ Time Frame: 5 Days ]

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

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
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
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 |