A Phase 2 interventional study of Sunitinib in Sarcoma, Soft Tissue, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-04.
Sponsored by Columbia University · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib.
Soft tissue sarcomas are rare tumors that arise from mesenchymal tissue from anywhere in the body. While surgical intervention can offer a cure for localized soft tissue sarcoma, treatment of unresectable and metastatic disease is particularly challenging. New treatment options are needed for patients with unresectable or metastatic disease if they progress or cannot tolerate conventional chemotherapy. This study will investigate sunitinib - a novel orally-administered multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens.
Drug: Sunitinib
Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
Also known as: Sutent, Sunitinib malate, SU011248
Number of Subjects With Stable Disease at First Assessment of Response
CT or MRI to monitor response: CT or MRI to assess tumor measurement based on the RECIST criteria
Time frame: Up to 84 days
| Milestone | Sunitinib |
|---|---|
| Started | 9 |
| Completed | 1 |
| Not completed | 8 |
| Withdrew: Adverse event | 3 |
| Withdrew: Progressive disease | 2 |
| Withdrew: Non-compliance | 3 |
CT or MRI to monitor response: CT or MRI to assess tumor measurement based on the RECIST criteria
| participants | Sunitinib |
|---|---|
| Number of Subjects With Stable Disease at First Assessment of Response | 6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib | — | 1/9 (11.1%) | 5/9 (55.6%) |
| Event | Sunitinib |
|---|---|
| Acute Myocardial InfarctionCardiac disorders | 1/9 |
| Event | Sunitinib |
|---|---|
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 2/9 |
| FatigueGeneral disorders | 1/9 |
| MucositisGastrointestinal disorders | 1/9 |
| NauseaGastrointestinal disorders | 1/9 |
| VomitingGastrointestinal disorders | 1/9 |
| Night sweatsGeneral disorders | 1/9 |
| Upper Respiratory InfectionGeneral disorders | 1/9 |
10 subjects were consented; however, 1 subject decided to pursue treatment elsewhere prior to receiving study drug after consent.
| Age, Categorical(Participants) | Sunitinib |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 7 |
| Sex: Female, Male(Participants) | Sunitinib |
|---|---|
| Female | 2 |
| Male | 7 |
| Region of Enrollment(participants) | Sunitinib |
|---|---|
| United States | 9 |
Plan to share: Undecided
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This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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