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

This study has been terminated.
(The study did not achieve the statistical success to continue.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00200382
First Posted: September 20, 2005
Last Update Posted: December 11, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by:
Montefiore Medical Center
September 13, 2005
September 20, 2005
December 11, 2007
May 2004
Not Provided
Response rate
Same as current
Complete list of historical versions of study NCT00200382 on ClinicalTrials.gov Archive Site
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Phase II Study of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: PS-341 (Velcade-drug)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
May 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00200382
Velcade
Not Provided
Not Provided
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Montefiore Medical Center
Millennium Pharmaceuticals, Inc.
Study Chair: Rasim Gucalp, M.D. Montefiore Medical Center
Montefiore Medical Center
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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