E2511 Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer
This research is being done to see if it is safe for subjects to take an additional investigational pill (veliparib) along with the standard chemotherapy (cisplatin and etoposide) for their lung cancer.
Healthy adults over 18 years of age who have extensive stage small cell lung cancer may be eligible. They must also have: Normal blood test results, No central nervous system involvement, No active or history of seizures, HIV-negative, and Must not be pregnant or breastfeeding.
Eligible subjects will receive standard chemotherapy cisplatin and etoposide as well as the study agent veliparib at the beginning of each cycle. Each cycle is 21 days long. The dose of veliparib will be determined by the study and is based on the side effects experienced by other subjects. After the second cycle, each subject will have imaging scans done to check the status of the tumor. If the tumor has not increased and the subject is tolerating veliparib, then the subject may receive another 2 cycles of the study regimen and no more than 4 total cycles. All subjects will be assessed by their study doctor prior to each cycle and monitored after they have completed the study regimen, up to 3 years.
05/21/2013 04:02 AM