Last updated: 11/04/2018 08:33:44
Ispinesib In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer
GSK study ID
KSP20007
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Ispinesib
Enrollment:
70
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Non-Small-Cell Lung Cancer
Product
ispinesib
Collaborators
Not applicable
Study date(s)
December 2003 to October 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
no
- 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.
- Received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function.
- Females who are pregnant.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27403
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32224
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14623
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38104
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-04-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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