A Phase II Study of MLN8237 in Patients with Recurrent or Persistent Uterine Leiomyosarcoma

Protocol
12-164
Full Title
A Phase II Evaluation of MLN8237 (NSC# 747888 IND #113149) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus (GOG-0231D)
Purpose

The purpose of this Gynecologic Oncology Group study is to evaluate the safety and effectiveness of an investigational drug called MLN8237 in women with leiomyosarcoma of the uterus that has returned or continues to grow despite prior therapy. 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).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have leiomyosarcoma of the uterus that has returned or continues to grow despite at least one but no more than two prior regimens of chemotherapy.
  • At least 3 weeks must have passed since completion of prior therapy (1 week since hormonal therapy) and entry into the study.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. David Hyman at 646-888-4544.

Disease(s)
Endometrial and other Uterine Cancers: Leiomyosarcoma
Endometrial and other Uterine Cancers: Uterine Cancer
Leiomyosarcoma
Sarcomas
Sarcomas: Leiomyosarcoma
Sarcomas: Soft Tissue Sarcoma
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