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TerminatedNCT00200382Updated Aug 2, 2018

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

A Phase 2 interventional study of PS-341 (Velcade-drug) in Non-small Cell Lung Cancer, sponsored by Rasim Gucalp. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-02.

Sponsored by Rasim Gucalp · Phase 2, Interventional, and Treatment

Why this study was terminated
The study did not achieve the statistical success to continue.

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled May 2004, registered Sep 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 27 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

This is the only study on the registry with Rasim Gucalp as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Untreated symptomatic brain metastasis Patients with known HIV positivity
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Interventions

  • DrugPS-341 (Velcade-drug)
06

What researchers measure

Primary outcomes

  1. Response rate

07

Study locations

5 sites
  • HealthAlliance Hospitals
    Fitchburg, Massachusetts 01420, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Albert Einstein Cancer Center
    Bronx, New York 10461, United States
  • Jacobi Medical Center
    Bronx, New York 10461, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00200382
Lead sponsor
Rasim Gucalp
Collaborators
Millennium Pharmaceuticals, Inc.
Responsible party
Rasim Gucalp (Prof. Dept of Medicine (Oncology), Montefiore Medical Center) — Sponsor-investigator
First posted
Sep 20, 2005
Start date
May 2004
Primary completion
May 2007
Completion
May 2007
Last update
Aug 2, 2018

Study contacts

Rasim Gucalp, M.D.
study chair · Montefiore Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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