Protocol
12-100
Full Title
Randomized Phase 2 Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel or Weekly Paclitaxel Alone in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Preceded by a Phase 1 Portion in Patients with Ovarian or Breast Cancer
Purpose
Paclitaxel is part of the standard therapy for ovarian, fallopian tube, and primary peritoneal cancers. However, these cancers often continue growing despite this treatment. The purpose of this study is to assess the safety and effectiveness of adding the investigational drug MLN8237 (alisertib) to paclitaxel therapy in women with recurrent ovarian, fallopian tube, and primary peritoneal cancers. MLN8237 may increase the effectiveness of drugs like paclitaxel.
MLN8237 works by blocking aurora kinase, an enzyme that helps cancer cells divide and reproduce. MLN8237 is a pill that is taken orally (by mouth). Women will be randomly assigned to receive paclitaxel plus MLN8237 or paclitaxel alone.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have ovarian, fallopian tube, or primary peritoneal cancer that returned despite prior therapy which included both a platinum-containing drug and a taxane.
- At least 3 weeks must have passed since completion of prior therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is open to patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. William Tew at 646-888-4220.
Disease(s)
Ovarian Cancer
Locations
Related Diseases
