Non-Small-Cell Lung Cancer
Conditions
Keywords
Platinum-Refractory, Platinum-Relapsed, Non-Small Cell Lung Cancer
Brief 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. 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.
Interventions
DRUGIspinesib
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Overall Response Rate of tumor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability: adverse events, changes from baseline in vital signs and clinical laboratory parameters. | — |
Countries
Belgium, United Kingdom, United States
Outcome results
None listed