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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00290550
• Other study ID #: 0457-006
• Secondary ID: 2006_008
• Status: Terminated
• Phase: Phase 2
• First received: February 9, 2006
• Last updated: July 24, 2015
• Start date: June 2006
• Est. completion date: May 2007

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• MK0457
IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 Days	No
Secondary	Safety and tolerability as measured by duration, intensity (grade) and time of onset of toxicity.		5 Days	Yes