Cabozantinib for Adults With Advanced Soft Tissue Sarcoma

Conditions

• Refractory Soft Tissue Sarcomas

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib — DRUG
  Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).

Study Details

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.

Key Dates

Start date

Jan 15, 2013

Status verified

Dec 2023

Primary completion

Sep 30, 2020

Completion

Sep 11, 2023

Study Design

Enrollment

55 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cabozantinib
  60 mg tablets orally once a day in a 28-day cycle.

Primary Outcome Measure

Objective Response (Complete Response (CR)+Partial Response (PR) of Cabozantinib in Patients With Soft Tissue Sarcomas [ Time Frame: Date treatment consent signed to date off study, approximately 86 months and 3 days. ]

Locations (1)

Find similar trials in Bethesda, MD