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)
Data Collection
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: December 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
GSK Investigational Site
Jacksonville, United StatesGSK Investigational Site
Rochester, United StatesGSK Investigational Site
Rochester, United States