Cabozantinib for Adults With Advanced Soft Tissue Sarcoma

Cabozantinib for Adults With Advanced Soft Tissue Sarcoma

Solid Tumors

Active, not recruiting

2

Start Date 12/01/2012

Age of Trial (yrs) 12

Gleevec-resistant

KIT/PDGFRA inhibitor + MET/VEGF inhibitor

Block KIT + Block related tumor signal paths

GIST not specified. GIST patient enrollment unknown.

130044, 13-C-0044

National Cancer Institute (NCI)

Jennifer H Zlott (301) 435-5664 zlottjh@mail.nih.gov Alice P Chen, M.D. (301) 496-4291 chenali@mail.nih.gov

Oral

Background:

- Cabozantinib is a cancer treatment drug that blocks the growth of new blood vessels in tumors. It can also block a chemical on tumor cells that allows the cells to grow. A similar drug, pazopanib, is used to treat types of cancer known as sarcomas. Researchers want to see if cabozantinib can be an effective treatment for types of soft tissue sarcoma that have not responded to earlier treatments.

Objectives:

- To test the effectiveness of cabozantinib for soft tissue sarcomas that have not responded to standard treatments.

Eligibility:

- Individuals at least 18 years of age who have soft tissue sarcomas that have not responded to standard treatments.

Design:

Participants will be screened with a physical exam and medical history. Blood samples will be collected. Imaging studies and other tests will be used to study the tumor before the start of treatment.
Participants will take cabozantinib tablets daily for 28-day cycles of treatment. The tablets should be taken whole on an empty stomach.
Treatment will be monitored with frequent blood tests and imaging studies. - Participants will continue to take cabozantinib for as long as the tumor does not become worse and the side effects are not too severe.

Detailed Description:

Background:

Soft tissue sarcomas (STS) are a relatively rare heterogeneous group of tumors that constitute about 1% of adult cancers.
The mainstay of treatment for advanced disease has been palliative chemotherapy with a median overall survival of approximately 12 months. This has not changed considerably in the past years and there is an unmet need for newer targeted therapies.
VEGF levels are elevated in patients with STS and various sarcoma cell lines express high levels of activated c-Met receptor.
We hypothesize that dual targeting of the VEGF and c-MET pathways with cabozantinib would result in clinical benefit in patients with soft tissue sarcoma.