Back to resultsA Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)
Primary Purpose
Neoplasms
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK0683, vorinostat
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Non-Small Cell Lung Cancer (NSCLC)
Eligibility Criteria
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
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
Sites / Locations
Outcomes
Primary Outcome Measures
Number of Participants With a Dose Limited Toxicity at 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
Area Under the Curve (AUC(0-24 hr)) at 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
Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.
Maximum Concentration (Cmax) at Day 4
Maximum Concentration (Cmax) = the maximum plasma concentration of the drug
Maximum Concentration (Cmax) at Day 5
Maximum Concentration (Cmax) = the maximum plasma concentration of the drug
Full Information
NCT ID
NCT00424775
First Posted
January 19, 2007
Last Updated
March 31, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00424775
Brief Title
A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)
Official Title
A Phase I Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
Non-Small Cell Lung Cancer (NSCLC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0683, vorinostat
Other Intervention Name(s)
MK0683
Intervention Description
vorinostat 300 mg or 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
Primary Outcome Measure Information:
Title
Number of Participants With a Dose Limited Toxicity at First Cycle
Description
Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.
Time Frame
25 Days (first cycle)
Secondary Outcome Measure Information:
Title
Area Under the Curve (AUC(0-24 hr)) at Day 4
Description
Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.
Time Frame
Day 4
Title
Area Under the Curve (AUC(0-24 hr)) at Day 5
Description
Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.
Time Frame
Day 5
Title
Maximum Concentration (Cmax) at Day 4
Description
Maximum Concentration (Cmax) = the maximum plasma concentration of the drug
Time Frame
Day 4
Title
Maximum Concentration (Cmax) at Day 5
Description
Maximum Concentration (Cmax) = the maximum plasma concentration of the drug
Time Frame
Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)
We'll reach out to this number within 24 hrs