Back to resultsPhase II Study of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PS-341 (Velcade-drug)
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- HealthAlliance Hospitals
- Dartmouth-Hitchcock Medical Center
- Albert Einstein Cancer Center
- Jacobi Medical Center
- Montefiore Medical Center
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Full Information
NCT ID
NCT00200382
First Posted
September 13, 2005
Last Updated
July 31, 2018
Sponsor
Rasim Gucalp
Collaborators
Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00200382
Brief Title
Phase II Study of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer
Official Title
Phase II Study to Evaluate the Efficacy and Safety of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
The study did not achieve the statistical success to continue.
Study Start Date
May 2004 (Actual)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rasim Gucalp
Collaborators
Millennium Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PS-341 (Velcade-drug)
Primary Outcome Measure Information:
Title
Response rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasim Gucalp, M.D.
Organizational Affiliation
Montefiore Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
HealthAlliance Hospitals
City
Fitchburg
State/Province
Massachusetts
ZIP/Postal Code
01420
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer
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