Non-Small-Cell Lung CancerPhase 2NCT00085813
Ispinesib In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Ispinesib in people with Non-Small-Cell Lung Cancer, run by GlaxoSmithKline at 11 sites in 3 countries.
Trial summary
This study was designed to determine how effective and safe Ispinesib is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Ispinesib
- How many people
- 70 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Dec 2003to Oct 2005
- 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
- Must have received only one prior platinum-based chemotherapy regimen.
- Blood tests will be done to check if blood counts are adequate for taking part in the study.
Who cannot join
- Received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function.
- Females who are pregnant.
- Any unstable, pre-existing major medical condition or history of other cancers.
- Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States7 sites
GSK Investigational Site
Greensboro, North Carolina, 27403
GSK Investigational Site
Jacksonville, Florida, 32224
GSK Investigational Site
Memphis, Tennessee, 38104
GSK Investigational Site
Philadelphia, Pennsylvania, 19111
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Rochester, New York, 14623
GSK Investigational Site
Scottsdale, Arizona, 85259
Belgium3 sites
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Leuven, 3000
About this study
Official title: A Phase II, Open-Label Study of Ispinesib in Subjects With Locally Advanced or Metastatic Platinum-Refractory or Platinum-Relapsed Non-Small Cell Lung Cancer (NSCLC)
This study was designed to determine how effective and safe Ispinesib is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Ispinesib
- Keywords
- Platinum-Refractory, Platinum-Relapsed, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IspinesibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Overall Response Rate of tumor.
Secondary outcomes (1)
Safety and tolerability: adverse events, changes from baseline in vital signs and clinical laboratory parameters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2004 (estimated)
- Study startDec 2003
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085813
- Sponsor's protocol ID
- KSP20007
- Status last verified
- Oct 2010
- First submitted
- 14 Jun 2004
- Last updated
- 4 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label Study of Ispinesib in Subjects With Locally Advanced or Metastatic Platinum-Refractory or Platinum-Relapsed Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00085813
- Acronym / sponsor ID
- KSP20007
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- Platinum-Refractory, Platinum-Relapsed, Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 17 Jun 2004 (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.
This study was designed to determine how effective and safe Ispinesib is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.
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 (2 listed)
- Must have received only one prior platinum-based chemotherapy regimen.
- Blood tests will be done to check if blood counts are adequate for taking part in the study.
Key exclusion criteria (4 listed)
- Received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function.
- Females who are pregnant.
- Any unstable, pre-existing major medical condition or history of other cancers.
- Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.
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 |
|---|---|---|
| Ispinesib | Drug | – |
Primary outcome
Assessment of Overall Response Rate of tumor.
1 secondary outcome
Safety and tolerability: adverse events, changes from baseline in vital signs and clinical laboratory parameters.
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 4 Oct 2010.
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ispinesib in people with Non-Small-Cell Lung Cancer, run by GlaxoSmithKline at 11 sites in 3 countries.
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 2 inclusion and 4 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 4 Oct 2010. 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, Belgium, United Kingdom. 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.
What does the primary outcome measure?
Assessment of Overall Response Rate of tumor.. It is what the study was designed to measure, not a finding.
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 4 Oct 2010.