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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00042679
Other study ID # 6429
Secondary ID H7X-MC-JVAB
Status Completed
Phase Phase 2
First received August 2, 2002
Last updated July 18, 2006
Start date June 2002

Study information

Verified date July 2006
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

Definition: The phase 2 study will provide important information regarding effects of LY900003 on safety and efficacy of patients treated with gemcitabine and carboplatin. LY900003 will be given at approximately 2 mg/kg/day for the first 14 days of a 21-day cycle. The dose and schedule for LY900003 administration are based on results of prior studies of LY900003 and are currently being used in other studies of LY900003. Gemcitabine will be administered on Days 1 and 8 at 1250 mg/m2 and carboplatin will be given on Day 1 at AUC 5.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Gemcitabine

Carboplatin

LY900003


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

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