Cabozantinib for Adults With Advanced Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT01755195|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : May 12, 2021
- 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.
- To test the effectiveness of cabozantinib for soft tissue sarcomas that have not responded to standard treatments.
- Individuals at least 18 years of age who have soft tissue sarcomas that have not responded to standard treatments.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Refractory Soft Tissue Sarcomas||Drug: Cabozantinib||Phase 2|
- 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.
- Assess the response rate (CR+PR) of cabozantinib in patients with soft tissue sarcomas.
- Assess the 6 month progression free survival (PFS) of cabozantinib in soft tissue sarcomas.
-Determine and compare circulating levels of HGF, soluble MET (sMET), VEGF-A, and soluble VEGFR2 (sVEGFR2) prior to and following administration of cabozantinib.
- Patients must have had disease progression following one line of standard therapy
- Age greater than or equal to 18 years.
- Adequate organ function.
- Patients will be stratified based on prior VEGFR TKI therapy.
- All patients will receive cabozantinib at 60 mg PO daily in 4 week cycles.
- Tumor response evaluations by imaging will be done every 2 cycles (less frequently for patients on study more than one year).
- The study will be conducted as a dual-endpoint two-stage Phase II trial to target objective tumor response rate (CR+PR) of 30% against an unacceptably low rate of 10%, and 6-month PFS rate of 65% against an unacceptably low rate of 45% (corresponding to median PFS of 9.6 vs. 5.2 months).
- The trial will accrue up to 55 patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Cabozantinib (XL184), a Dual Inhibitor of MET and VEGFR, in Patients With Metastatic Refractory Soft Tissue Sarcoma|
|Actual Study Start Date :||January 15, 2013|
|Actual Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2021|
60 mg tablets orally once a day in a 28-day cycle.
Cabozantinib inhibits multiple RTKs implicated in tumor growth, metastasis, and angiogenesis, and targets primarily MET and VEGFR2.
- Response rate [ Time Frame: 8 weeks ]Response rate (CR+PR) of cabozantinib in patients with soft tissue sarcomas
- Progression free survival (PFS) [ Time Frame: 6 months ]6 month progression free survival (PFS) in patients with soft tissue sarcomas treated with cabozantinib
- levels of HGF, soluble MET, VEGF-A, and soluble VEGFR2 [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755195
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Alice P Chen, M.D.||National Cancer Institute (NCI)|