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

July 31, 2018 updated by: Rasim Gucalp

Phase II Study to Evaluate the Efficacy and Safety of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Fitchburg, Massachusetts, United States, 01420
        • HealthAlliance Hospitals
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Bronx, New York, United States, 10461
        • Albert Einstein Cancer Center
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rasim Gucalp

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Study Chair: Rasim Gucalp, M.D., Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-05-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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