|MDACC Study No:||2013-0190 (clinicaltrials.gov NCT No: NCT01952249)|
|Title:||A Phase 1b/2 Study of Demcizumab plus Paclitaxel in Subjects with Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer|
|Principal Investigator:||Robert Coleman|
|Treatment Agent:||Demcizumab; Paclitaxel; Placebo |
|Study Description:||This clinical research study is made up of 2 phases: Phase 1b and Phase 2. |
Phase 1a has already been completed. Its goal was to find the highest
tolerable dose of demcizumab when given by itself.
The goal of Phase 1b of this study is to learn the highest tolerable dose of
demcizumab that can be given in combination with paclitaxel.
The goal of Phase 2 of this study is to learn if the combination of demcizumab
and paclitaxel can help to control ovarian, peritoneal, or fallopian tube
cancer. To do this, researchers will compare demcizumab to a placebo. A
placebo is not a drug. It looks like the study drug but is not designed to
treat any disease or illness. It is designed to be compared with a study drug
to learn if the study drug has any real effect.
The safety of the drug combination will be studied in both phases.