Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Gemcitabine; Drug: vorinostat; Drug: Platinum-based agent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00423449

2006_528

0683-058

Details and patient eligibility

About

This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Vorinostat + Gemcitabine + Platinum-based agent

Experimental group

Treatment:

Drug: Platinum-based agent

Drug: vorinostat

Drug: Gemcitabine