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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0683, vorinostat

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.

Intervention Type DRUG

Other Intervention Names

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MK0683

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No