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

Phase 1TerminatedNCT00424775

Merck Sharp & Dohme LLC3 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

MK0683, vorinostatDRUG

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

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 25 Days (first cycle)

Secondary Outcomes

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.

Time frame: Day 4

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.

Time frame: Day 5

Maximum Concentration (Cmax) at Day 4

Maximum Concentration (Cmax) = the maximum plasma concentration of the drug

Time frame: Day 4

Maximum Concentration (Cmax) at Day 5

Maximum Concentration (Cmax) = the maximum plasma concentration of the drug

Time frame: Day 5

Data from ClinicalTrials.gov

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