A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer.
2 other identifiers
interventional
N/A
1 country
11
Brief Summary
The purposes of this study are to determine the following: Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear, and for how long. If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer. The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be associated with the combination of these three drugs. How LY900003 is distributed and broken down by your body when it is given with carboplatin and gemcitabine. Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down by your body.
Trial Health
Trial Health Score
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11 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 2, 2002
CompletedFirst Posted
Study publicly available on registry
August 6, 2002
CompletedJuly 19, 2006
July 1, 2006
August 2, 2002
July 18, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Non-Small-Cell Lung Cancer.
- Stage IV or Stage IIIB disease.
- ECOG Performance Status of 0 or 1.
- Adequate organ function
- One unidimensionally measurable lesion.
You may not qualify if:
- Prior therapy for NSCLC.
- Serious concomitant disorders.
- Untreated CNS metastases.
- Uncontrolled, active infection.
- Previous LY900003/ISIS trial participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Berkeley, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Miami Beach, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Park Ridge, Illinois, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Chattanooga, Tennessee, United States
Unknown Facility
Lubbock, Texas, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Milwaukee, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 2, 2002
First Posted
August 6, 2002
Study Start
June 1, 2002
Last Updated
July 19, 2006
Record last verified: 2006-07