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TerminatedNCT00859456Updated Nov 4, 2019Results posted

Sunitinib in Certain Subtypes of Soft Tissue Sarcomas

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

Why this study was terminated
Closed by pharmaceutical sponsor

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2007, registered Mar 2009).
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Sarcoma, Soft Tissue

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03

In context

Sarcoma

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histopathologically-proven diagnosis of angiosarcoma, epithelioid sarcoma-like hemangioendothelioma or Kaposi's sarcoma. Both HIV-Related and HIV-Unrelated Kaposi's patients will be included in the trial. Patients with HIV-Related Kaposi's will be required to have a CD4 count >50 cells/µL and Viral Load \< 50 copies/ml. They will also need to be willing to take HAART. They can either have stable Kaposi's on HAART for at least 3 months or have progression of their Kaposi's after having been on HAART for at least 10 weeks.
  • Not amenable to surgery, radiation, or combined modality treatment with curative intent.
  • Evidence of unidimensionally measurable disease by conventional radiographic techniques. In patients with Kaposi's sarcoma, skin lesions at least 10 mm will be considered measurable disease. Bone lesions, ascites, or lymphangitis of skin or lung are not considered measurable.
  • No more than 2 prior chemotherapy regimens for metastatic or unresectable disease. Patients may have received prior bevacizumab or other Tyrosine Kinase Inhibitors, excluding sunitinib. Treatment with bevacizumab or other Tyrosine Kinase Inhibitors will not be counted as prior chemotherapy regimens.
  • Four weeks since prior chemotherapy, surgery or radiation therapy and resolution of all toxic effects of any prior therapy, surgical procedure or radiation.
  • ECOG performance status 0-2.
  • Age 18 or greater.

Exclusion criteria

Exclusion Criteria:

  • Patients with a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
  • No areas of measurable disease by CT or MRI.
  • Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident. or transient ischemic attack, or pulmonary embolism.
  • Ongoing cardiac dysrhythmias, atrial fibrillation or prolongation of the QTc interval to >450 msec for males of > 470 msec for females. Medications that may prolong the QT intervals should be discontinued or switched to another medication prior to starting Sutent unless determined by the investigator to be absolutely necessary.
  • Pregnancy or breastfeeding.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with the study participation or study drug administration.
  • Major surgery or radiation therapy within 4 weeks of starting the study treatment.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Sunitinib

    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

Interventions

  • DrugSunitinib

    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

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What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Nov 4, 2019

Participant flow

Participant flow — Overall Study
MilestoneSunitinib
Started9
Completed1
Not completed8
Withdrew: Adverse event3
Withdrew: Progressive disease2
Withdrew: Non-compliance3

Outcome measures

PrimaryNumber 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
Reported as:
Number · participants
Number of Subjects With Stable Disease at First Assessment of Response
participantsSunitinib
Number of Subjects With Stable Disease at First Assessment of Response6

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sunitinib—1/9 (11.1%)5/9 (55.6%)
Most frequent serious events
Most frequent serious events
EventSunitinib
Acute Myocardial InfarctionCardiac disorders1/9
Most frequent other events
Most frequent other events
EventSunitinib
Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders2/9
FatigueGeneral disorders1/9
MucositisGastrointestinal disorders1/9
NauseaGastrointestinal disorders1/9
VomitingGastrointestinal disorders1/9
Night sweatsGeneral disorders1/9
Upper Respiratory InfectionGeneral disorders1/9

Baseline characteristics

10 subjects were consented; however, 1 subject decided to pursue treatment elsewhere prior to receiving study drug after consent.

Age, Categorical
Age, Categorical(Participants)Sunitinib
<=18 years0
Between 18 and 65 years2
>=65 years7
Sex: Female, Male
Sex: Female, Male(Participants)Sunitinib
Female2
Male7
Region of Enrollment
Region of Enrollment(participants)Sunitinib
United States9
08

Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00859456
Lead sponsor
Columbia University
Responsible party
Sponsor
First posted
Mar 11, 2009
Start date
Apr 2007
Primary completion
Nov 2012
Completion
Feb 2013
Results posted
Nov 4, 2019
Last update
Nov 4, 2019

Study contacts

Robert N Taub, MD, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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