Carcinoma, Non-Small-Cell LungPhase 2NCT00042679
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.
A Phase 2 study testing Gemcitabine, Carboplatin and LY900003 in people with Carcinoma, Non-Small-Cell Lung and Pulmonary Neoplasms, run by Eli Lilly and Company at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Pulmonary Neoplasms, Neoplasms, Lung
- What is being tested?
- Gemcitabine, Carboplatin and LY900003
- How many people
- Not given
- Where
- 11 sitesUnited States
- Study dates
- Jun 2002to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Prior therapy for NSCLC.
- Serious concomitant disorders.
- Untreated CNS metastases.
- Uncontrolled, active infection.
- Previous LY900003/ISIS trial participation.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Bakersfield, California
Study site
Baltimore, Maryland
Study site
Berkeley, California
Study site
Charlottesville, Virginia
Study site
Chattanooga, Tennessee
Study site
Chicago, Illinois
Study site
Lubbock, Texas
Study site
Miami Beach, Florida
Study site
Milwaukee, Wisconsin
Study site
Park Ridge, Illinois
Study site
Torrance, California
About this study
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.
Read the detailed 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.
- Being tested
- Gemcitabine, Carboplatin, LY900003
- Keywords
- Non-Small-Cell Lung Cancer, Adenocarcinoma, Carcinoma Squamous, Adult Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Adenocarcinoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
CarboplatinDrug
LY900003Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2002 (estimated)
- Study startJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042679
- Sponsor's protocol ID
- 6429
- Other IDs
- H7X-MC-JVAB
- Status last verified
- Jul 2006
- First submitted
- 2 Aug 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00042679
- Acronym / sponsor ID
- 6429
- Keywords
- Non-Small-Cell Lung Cancer, Adenocarcinoma, Carcinoma Squamous, Adult Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- First posted
- 6 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Prior therapy for NSCLC.
- Serious concomitant disorders.
- Untreated CNS metastases.
- Uncontrolled, active infection.
- Previous LY900003/ISIS trial participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine | Drug | – |
| Carboplatin | Drug | – |
| LY900003 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Carboplatin and LY900003 in people with Carcinoma, Non-Small-Cell Lung and Pulmonary Neoplasms, run by Eli Lilly and Company at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2006.