Full TitleA Phase 2 Multi-Center Investigation of Efficacy of ABI-009 (Nab-Rapamycin) in Patients with Advanced Malignant Perivascular Epithelioid Cell Tumors (PEComa)(Version date 11-DEC-2015)
Perivascular epitheloid cell tumors (PEComas) are rare cancers that are usually treated with surgery or radiation therapy, but there is no single treatment approved for these cancers. In this study, researchers are assessing the safety and effectiveness of an investigational drug called ABI-009 (nab-rapamycin) in people with advanced PEComas that have continued to grow or came back despite treatment.
ABI-009 interferes with a biological pathway involved in PEComa growth. It is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an advanced PEComa that has continued to grow or came back despite treatment and cannot be surgically removed.
- At least 4 weeks must pass between completion of prior therapies 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 for people age 18 and older.