Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer
Intervention: vorinostat (Drug); Gemcitabine (Drug); Cisplatin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This is a clinical trial to determine the safety and tolerability of MK0683 (vorinostat) in
combination with gemcitabine and cisplatin and/or carboplatin.
Clinical Details
Official title: A Phase I Clinical Trial of Vorinostat in Combination With Gemcitabine Plus Platinum in Patients With Advanced Non-Small Cell Lung Cancer
Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Determine the maximum tolerated dose (MTD) of vorinostat administered for 7 to 14 days in repeated 21-day cycles in combination with standard doses of gemcitabine plus either cisplatin or carboplatin in previously chemo naive patients w/ advanced NSCLC
Secondary outcome: To assess at MTD the pharmacokinetics of vorinostat, gemcitabine and either cisplatin or carboplatin when administered in combination
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient must have a histologically-confirmed metastatic or locally advanced non-small
cell lung cancer that has not been previously treated with systemic chemotherapy or
has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant
chemotherapy if the last dose was at least 6 months prior to study enrollment
Exclusion Criteria:
- Patient who has had chemotherapy, radiotherapy, or biological therapy prior to
entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for
treatment of a tumor
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8 75114, France; Recruiting
Jean-Marie Goehrs, Phone: 33-1-4754-89-90
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: March 2007
Last updated: January 8, 2009
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