A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas
This study is for patients who have been diagnosed with soft tissue sarcoma that has spread (metastasized) or that is not eligible for removal by surgery. The purpose of this study is to determine how soft tissue sarcomas respond to treatment with an investigational drug called tivozanib. In some lab and clinical studies, tivozanib has been shown to interfere with the growth of some types of tumors. The study will also evaluate how safe the study treatment is by observing how many and what kind of adverse events (side effects) participants experience.
Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas|
- Progression-free survival from study disease will be evaluated using imaging scans (CT or MRI) [ Time Frame: Evaluation takes place after 16 weeks of treatment ] [ Designated as safety issue: No ]Progression-free survival from study disease will be evaluated using imaging scans (CT or MRI) following 16 weeks of treatment.
- Determine overall response rate [ Time Frame: Every 2 cycles (8 weeks) up to 2 years ] [ Designated as safety issue: No ]The response to study treatment will be assessed after every 8 weeks (2 cycles) of therapy using CT or MRI scan images.
- Determine the clinical benefit rate [ Time Frame: Every 2 cycles (8 weeks) up to 2 years ] [ Designated as safety issue: No ]The clinical benefit of study treatment will be assessed after 8 weeks (2 cycles) of therapy using scanning images (CT or MRI).
- Determine overall survival [ Time Frame: Time from the first dose of study treatment up to 2 years beyond disease progression ] [ Designated as safety issue: No ]Patients will be followed-up with from first dose of study drug up to 2 years following the date of disease progression.
- Evaluate proteins and correlate with response to therapy [ Time Frame: Tissue collected during screening process (prior to study start date) ] [ Designated as safety issue: Yes ]Tissue from biopsy will be collected during screening and proteins (VEGFR1 and VEGFR2) will be evaluated to see if there is a correlation with patient response to treatment.
- Treatment toxicity as measured by adverse events experienced while on treatment [ Time Frame: After every 4 weeks (1 cycle) ] [ Designated as safety issue: Yes ]Toxicity will be assessed after 4 weeks (1 cycle).
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (tivozanib)
Patients receive tivozanib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
I. To determine the progression-free survival (defined as complete response [CR] + partial response [PR] + stable disease [SD]) assessed at 16 weeks for patients treated with tivozanib.
I. Overall response rate (defined as CR + PR). II. Clinical benefit rate (CR + PR + SD). III. Overall survival (up to 2 years beyond progression). IV. Correlation of clinical outcome with antibodies for vascular endothelial growth factor receptor 1 (VEGFR1) and VEGFR2.
V. Assess Safety and tolerability.
Patients receive tivozanib orally (PO) daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity, or until discontinuation per patient preference or physician recommendation.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782313
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52246|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Mark Agulnik, MD||Northwestern University|