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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Neoplasms

Treatments: Drug: MK0683, vorinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424775

0683-066

2007_001

Details and patient eligibility

About

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

Enrollment: 3 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)