Adults 18 to 120, any sex, with Refractory Soft Tissue Sarcomas. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response (Complete Response (CR)+Partial Response (PR) of Cabozantinib in Patients With Soft Tissue SarcomasPrimary· Date treatment consent signed to date off study, approximately 86 months and 3 days.
Objective response was assessed by the Response Evaluation Criteria in Solid Tumors RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
Cabozantinib
11.1
4.2 – 22.6
Percentage of Participants With 6 Month Progression Free Survival (PFS)Primary· 6 months
Progression in participants with soft tissue sarcomas treated with cabozantinib was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Group
Value
95% CI
Cabozantinib
49.3
36.2 – 67.3
Mean Change From Baseline in Levels of Circulating Hepatocyte Growth Factor (HGF)Secondary· Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1
Blood samples were collected before treatment on the first day of cycles 1 and 2 to determine circulating levels of HGF. HGF protein content (in picograms; pg) in blood plasma (in milliliters; mL) was measured for each sample with a two-site immunoassay and the difference from before to after treatment for each patient was reported. A change in this biomarker from the baseline value has not been linked to clinical outcomes; that is, it is neither a good or a bad outcome.
Baseline to Cycle 1 Day 1
Group
Value
95% CI
Cabozantinib
-51.3
-235.5 – 151.0
Baseline to Cycle 2 Day 1
Group
Value
95% CI
Cabozantinib
344.8
4.1 – 685.6
Mean Change From Baseline in Levels of Circulating Soluble Mesenchymal Epithelial Transition Factor (sMET)Secondary· Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1
Blood samples were collected before treatment on the first day of cycles 1 and 2 to determine circulating levels of soluble MET (sMET). sMET protein content (in nanograms; ng) in blood plasma (in milliliters; mL) was measured for each sample with a two-site immunoassay and the difference from before to after treatment for each patient was reported. A change in this biomarker from the baseline value has not been linked to clinical outcomes; that is, it is neither a good or a bad outcome.
Baseline to Cycle 1 Day 1
Group
Value
95% CI
Cabozantinib
-6.1
-12.0 – -0.3
Baseline to Cycle 2 Day1
Group
Value
95% CI
Cabozantinib
16.4
3.4 – 29.4
Mean Change From Baseline in Levels of Circulating Vascular Endothelial Growth Factor A (VEGF-A)Secondary· Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1
Blood samples were collected before treatment on the first day of cycles 1 and 2 to determine circulating levels of VEGF-A. VEGF-A protein content (in picograms; pg) in blood plasma (in milliliters; mL) was measured for each sample with a two-site immunoassay and the difference from before to after treatment for each patient was reported. A change in this biomarker from the baseline value has not been linked to clinical outcomes; that is, it is neither a good or a bad outcome.
Baseline to Cycle 1 Day 1
Group
Value
95% CI
Cabozantinib
5.6
-3.6 – 14.7
Baseline to Cycle 2 Day 1
Group
Value
95% CI
Cabozantinib
32.5
6.5 – 58.5
Mean Change From Baseline in Levels of Circulating Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR-2)Secondary· Baseline to Cycle 1 Day 1 and baseline to Cycle 2 Day 1
Blood samples were collected before treatment on the first day of cycles 1 and 2 to determine circulating levels of soluble VEGFR2 (sVEGFR-2). sVEGFR-2 protein content (in nanograms; ng) in blood plasma (in milliliters; mL) was measured for each sample with a two-site immunoassay and the difference from before to after treatment for each patient was reported. A change in this biomarker from the baseline value has not been linked to clinical outcomes; that is, it is neither a good or a bad outcome..
Baseline to Cycle 1 Day 1
Group
Value
95% CI
Cabozantinib
-1.0
-2.6 – 0.6
Baseline to Cycle 2 Day 1
Group
Value
95% CI
Cabozantinib
-10.9
-13.5 – -8.4
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)Secondary· Date treatment consent signed to date off study, approximately 86 months and 3 days.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent
Group
Value
95% CI
Cabozantinib
53
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately 86 months and 3 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cabozantinib
Serious: 14/54 (26%)
Deaths: 3/54
Serious adverse events (29 terms)
Reaction
System
Cabozantinib
Thromboembolic event
Vascular disorders
—
Vomiting
Gastrointestinal disorders
—
Abdominal pain
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
Small intestinal obstruction
Gastrointestinal disorders
—
Anemia
Blood and lymphatic system disorders
—
Cerebrospinal fluid leakage
Nervous system disorders
—
Dehydration
Metabolism and nutrition disorders
—
Diarrhea
Gastrointestinal disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Fatigue
General disorders
—
General disorders and administration site conditions - Other, fever
General disorders
—
Headache
Nervous system disorders
—
Hematuria
Renal and urinary disorders
—
Hypophosphatemia
Metabolism and nutrition disorders
—
Muscle weakness trunk
Musculoskeletal and connective tissue disorders
—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
—
Pneumothorax
Respiratory, thoracic and mediastinal disorders
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Serum amylase increased
Investigations
—
Stroke
Nervous system disorders
—
Supraventricular tachycardia
Cardiac disorders
—
Syncope
Nervous system disorders
—
Other adverse events (233 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07293351 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Caboz
· Phase 1, PHASE2
· recruiting
NCT07187869 — Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell
· Phase 1
· not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
· Phase 3
· recruiting
NCT06900595 — Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescent
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 3 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01755195.