A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)
A Phase I Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)
2 other identifiers
interventional
3
0 countries
N/A
Brief Summary
The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2007
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedResults Posted
Study results publicly available
June 1, 2009
CompletedApril 20, 2015
March 1, 2015
2 months
January 19, 2007
April 3, 2009
March 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
25 Days (first cycle)
Secondary Outcomes (4)
Area Under the Curve (AUC(0-24 hr)) at Day 4
Day 4
Area Under the Curve (AUC(0-24 hr)) at Day 5
Day 5
Maximum Concentration (Cmax) at Day 4
Day 4
Maximum Concentration (Cmax) at Day 5
Day 5
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2007
First Posted
January 22, 2007
Study Start
January 1, 2007
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
April 20, 2015
Results First Posted
June 1, 2009
Record last verified: 2015-03