Related Experiment Video
Updated: Aug 16, 2025
Establishment of a Primary Culture of Patient-derived Soft Tissue Sarcoma
Published on: April 11, 2018
A Single-Arm Phase II Trial of Sitravatinib in Advanced Well-Differentiated/Dedifferentiated Liposarcoma
Matthew Ingham1, Shing Lee2, Brian A Van Tine3
1Division of Hematology and Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, New York.
Purpose:
To evaluate sitravatinib, an inhibitor of multiple receptor tyrosine kinases (RTK), for the treatment of well-differentiated/dedifferentiated liposarcoma (WD/DD LPS).
Patients And Methods:
This multicenter, open-label, Phase II trial enrolled patients with advanced WD/DD LPS who had received at least one prior systemic regimen and had progression within 12 weeks of enrollment. Patients received sitravatinib 150 mg (later amended to 120 mg) orally daily. A Simon two-stage design was used to evaluate for an improvement in the primary endpoint, progression-free rate at 12 weeks (PFR12), from 20% to 40%. Secondary endpoints included antitumor activity and safety. A subset of patients underwent paired biopsies analyzed using reverse-phase protein array.
Results:
Twenty-nine patients enrolled. Median age was 62 years and 31% had received 3 or more prior lines. Most patients (93%) had DDLPS or mixed WD/DD LPS. Overall, 12 of 29 patients (41%) were alive and progression-free at 12 weeks and the study met the primary endpoint. There were no confirmed responses. Median progression-free survival was 11.7 weeks [95% confidence interval (CI): 5.9-35.9] and median overall survival was 31.7 weeks (95% CI: 18.1-90.1). The most common treatment-related adverse events were diarrhea (59%), hypertension (52%), hoarseness (41%), mucositis (31%), and nausea (31%). Baseline expression of phospho-RTKs was not significantly different between patients with and without clinical benefit from sitravatinib, but the number of samples was small.
Conclusions:
Sitravatinib provided a PFR12 of 41% and meaningful disease control in a subset of patients with advanced, progressive WD/DD LPS.
Insights
Sitravatinib showed a 41% progression-free rate at 12 weeks in patients with advanced liposarcoma, meeting the study
Area of Science:
- Oncology
- Pharmacology
- Medical Research
Background:
- Liposarcoma is a challenging soft tissue sarcoma.
- Advanced well-differentiated/dedifferentiated liposarcoma (WD/DD LPS) has limited treatment options.
- Receptor tyrosine kinases (RTKs) are implicated in cancer progression.
Purpose of the Study:
- To evaluate sitravatinib, a multi-RTK inhibitor, for advanced WD/DD LPS.
- To determine if sitravatinib improves progression-free survival.
- To assess antitumor activity and safety of sitravatinib.
Main Methods:
- A multicenter, open-label, Phase II trial.
- 29 patients with advanced WD/DD LPS received sitravatinib orally.
- Primary endpoint: progression-free rate at 12 weeks (PFR12).
Main Results:
- The study met its primary endpoint with a PFR12 of 41%.
- Median progression-free survival was 11.7 weeks.
- Common adverse events included diarrhea, hypertension, and hoarseness.
Conclusions:
- Sitravatinib demonstrated a 41% PFR12 in advanced WD/DD LPS.
- The drug provided meaningful disease control in a subset of patients.
- Further research may explore sitravatinib's role in liposarcoma treatment.
