A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)

Phase 1

Terminated

• Conditions: Neoplasms

• Registration Number: NCT00424775
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-19
• Study First Posted: 2007-01-22
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Results First Submitted: 2009-04-03
• Results First Submitted QC: 2009-04-03
• Results First Posted: 2009-06-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Chemotherapy-naive patients who are histologically or cytologically diagnosed NSCLC with stage IIIB (not applicable of radical thoracic radiation) or stage IV
• Patients with normal organ function and bone marrow function

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Exclusion Criteria

• Given radical thoracic radiation for NSCLC or radiation for other than original lesion within 3 weeks
• Any peripheral neuropathy above grade 2
• Any ascites, pleural effusion or pericardiac effusion which requires treatment
• Any uncontrolled concomitant illness
• Pregnant or breast-feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Dose Limited Toxicity at First Cycle	25 Days (first cycle)	Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.

Secondary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) at Day 4	Day 4	Maximum Concentration (Cmax) = the maximum plasma concentration of the drug
Maximum Concentration (Cmax) at Day 5	Day 5	Maximum Concentration (Cmax) = the maximum plasma concentration of the drug
Area Under the Curve (AUC(0-24 hr)) at Day 4	Day 4	Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.
Area Under the Curve (AUC(0-24 hr)) at Day 5	Day 5	Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.