Ovarian Cancer
Conditions
Keywords
ovarian cancer, platinum/taxane-refractory chemotherapy, Persistent, Recurrent
Brief summary
The purpose of this study is to determine how effective and safe a new investigational drug is in treating persistent or recurrent ovarian cancer in patients who have received a platinum/taxane based chemotherapy and whose disease continues to progress. The treatment involves a 1-hour treatment given intravenously (IV), and repeated once every 21 days. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over a 24 hour 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
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have a screening CA-125 of greater than or equal to 40 U/ml. * Must have received only one prior platinum/taxane-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 or nursing. * 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 |
|---|---|
| Overall response rate of Ispinesib administered as a 1-hour intravenous infusion once every 21 days | once every 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Assess safety/tolerability, progression-free survival, time-to-response, response duration, and characteristics of Ispinesib administered as an infusion once every 21 days | once every 21 days |
Countries
United States
Outcome results
None listed