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.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Carboplatin; Gemcitabine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Prior therapy for NSCLC.

• Serious concomitant disorders.

• Untreated CNS metastases.

• Uncontrolled, active infection.

• Previous LY900003/ISIS trial participation.