Phase II Study of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer

NCT ID: NCT00200382

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to develop new treatments that will hopefully result in the relief of symptoms and prolongation of life. For this reason, your doctors have offered you treatment with a new experimental drug called PS 341.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

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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PS-341 (Velcade-drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have confirmed NSCLC (squamous, adeno- and large cell anaplastic carcinoma)stage III B or Stage IV.

No prior chemotherapy regimen Patients must have adequate organ and marrow function

Exclusion Criteria

* Untreated symptomatic brain metastasis Patients with known HIV positivity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Rasim Gucalp

OTHER

Sponsor Role lead

Responsible Party

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Rasim Gucalp

Prof. Dept of Medicine (Oncology)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rasim Gucalp, M.D.

Role: STUDY_CHAIR

Montefiore Medical Center

Locations

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HealthAlliance Hospitals

Fitchburg, Massachusetts, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Albert Einstein Cancer Center

The Bronx, New York, United States

Site Status

Jacobi Medical Center

The Bronx, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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02-05-123

Identifier Type: -

Identifier Source: org_study_id

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